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IGNACE VALLEJO
718-946-0556 917-359-3028
525 Neptune Avenue, Brooklyn, New York 11224
ianvallejo@hotmail.com/ ianvallejo7@gmail.com
www.linkedin.com/in/ignacevallejo/
SUMMARY
• 15 years of experience in the Biotech/Pharmaceutical industry in Quality
Assurance and Quality Control with extensive regulatory requirement knowledge
• Conducted Product Investigations
• Inspection of all product packaging to determine a non-negative product impact
• Conducted both internal and external audits
• Conducted monthly GMP training for all new Employees regardless of position
• Delivered 100%, on time and before due date all reviews and releases of batch
records
• Initiated changes to S.O.P.'s to ensure compliance with all GMP's
• 10 years of experience conducting GMP audits CROs & Vendors
• Multiple European audits including France & Russia
AREAS OF EXPERTISE
• Fluent in Spanish, French, Italian and Portuguese
• Knowledge of GCP, cGMP, GLP, GXP requirements
• Certified Risk Management and Six Sigma "Black Belt"
• Certified Quality Auditor GMP
• Internal and external Audits
• International audit experience: UK. France, Spain, Italy, Japan and Germany
• National Audits: MA, CT, NJ, California, etc.
• Release of Raw Material.
• Batch reviews and release
• Medical/Scientific Writing
• QA/QC
• TrackWise, LIMS system, and Isotrain.
• Risk assessment, root cause, exception reports, CAPAs, deviation reports,
investigation analysis and non conformance
• 21 CFR part 211 guidelines
EXPERIENCE
Shire (Formerly Baxalta) 02/2016 – 07/2016 Consultant
At Baxalta acquired by Shire, Atlanta/GA ( Covington)
• Executed investigations in the Microbiology/Biochemistry Department and also have
written SOP's on OOS in the pharmaceutical Industry. I was a member of the upper
Management Team.
• Verified Non-viable and viable contamination by presenting Metrics for every department
through a power point presentation every other week.
• Executed Qualification Audits during product qualification (PQ), for a pharmaceutical
company that recently completed the construction of a multibillion dollar drug production
plant facility containing departments for pre and post (PQ’s) Fractionation, Albumin, IG,
Microbiology, Biochemistry, and Chemistry.
VIRBAC , USA. 05/2014 – 12/2015 Consultant
• Investigate deviations from QC department, this includes assessing the product
impact, determining the root cause and implementing appropriate CAPA utilizing
deviation data- base. (GMPs).
• Ensured all assigned SOPs are compliant with internal procedure and FDA
regulations.
• Execute Internal and External Audit (Vendors, CRO, CMO and Major
Pharmaceuticals)
Glatt Air Pharmaceutical Services, Ramsey, NJ 2/14 - 4/14
Senior Compliance Specialist Consultant
• Executed manufacturing investigations within the company for all products both liquid
and solid.
• Reviewed and approved internal audits of the facility.
• Closed CAPAs and deviations before due date.
• Planned International audits for the year in India and Germany.
• Investigated and wrote investigations.
• Performed internal/external audits, and trend investigations.
• Maintained training records, and updated spreadsheets for investigations, CAPAs,
monthly metrics, and GMP training.
Novartis, Suffern, NY 6/12 - 7/13
Consultant QSC Deviation Investigator
• Proposed, planned and established systems and procedures to ensure product quality and
compliance with cGMPs.
• Identify the root cause of a problem, then recommend and assure timely implementation
of appropriate corrective actions.
• Formulated solutions to the exception reports through meetings and 3rd party
teleconferences leading to product release.
• Identified true root cause of the incident.
• Execute Internal and External Audit (Vendors, CRO, CMO and Major Pharmaceuticals)
• Increased the effectiveness of the investigation, resulting in a lasting solution.
Lonza Biologics - Portsmouth, NH 3/12 - 6/12
Consultant Deviation Writer
• Investigated deviations from all departments, including assessment of product impact,
determining the root cause and implementing appropriate CAPA utilizing TrackWise
deviation database. (GMPs).
• Ensured all assigned deviation investigations were compliant with internal procedure and
FDA regulations.
• Proposed solutions to the exception reports through meetings, 3rd party teleconferencing
and investigations.
• Delivered investigations and exception reports on time by executing each investigation,
as follows:
• Description, Purpose of the step, Investigation Summary, Root Cause, Impact product
Quality, and Justification for no CAPA.
• Audited and monitored the compliance status of company quality related operations and
subcontractors.
• Reviewed and approved internal and external manufacturing records, batch records,
protocols, and analytical records.
• Monitored and reviewed and /or approved CAPAs, deviations, amendments,
investigations, out of specifications results and nonconformance.
BARCUSA, Inc., Lake Success, NY 3/11 - 6/11
Quality Assurance Manager GCP Consultant
• Executed clinical studies for multiple Global Pharmaceutical Companies in accordance
with the protocols, SOPs, ICH-GCP and other regulations and guidelines.
• Created scripts for GCP and provided regular clinical status information to team members
(Project Managers, and CRA).
• Served as the Single Point of Contact for selected CMOs, Pharma/Biotech,
Pharmaceuticals and CRO to assess quality and compliance with procedures, quality
agreements, Quality Systems Regulations.
• Performed and reported assigned GCP audits of studies including clinical investigators
sites, vendor/CROs, internal system/processes and clinical data and documents.
• Provided input to the annual audit plan, schedule and auditors.
• Prepared timely, well-written reports and obtained/evaluated audit responses while
managing CAPAs.
• Managed contract auditors as needed.
• Supported Health Authority inspection activities for domestic and international projects.
• Supported/provided quality system/GxP training to staff and developd/administered SOPs
as well as controlled FORMS.
• Maintained other controlled documents related to the QA unit and QA systems/tracking
mechanism for QA audits, CAPA, Quality Systems, etc.
• Maintained high degree of knowledge of global industry expectations, GCP regulations
and provide GCP expert advice/guidance to staff in support of GxP Operations.
• Assured that every test was performed as per protocols (Urine test, blood test, HIV test,
Serum, etc.)
• Developed SOPs under GCP guidelines and regulations.
• Executed Internal & External Audits.
• Conducted training On GCP and Good Documentation Practices.
• Created and maintained a strong relationship with the leadership team and participated in
all appropriate meetings and venues.
• Worked with the Clinical and Pharmacovigilance Management and Quality Management
team to ensure continuity.
• Worked with the Director of Quality Assurance & Auditing to ensure an appropriate
strategy and execution for audits through defined processes and practices.
• Ensured visibility to and management of any noted deviations or deficiencies through
trend and root cause analysis and worked with the appropriate team and internal QA Staff
to implement a CAPA system and processes.
• Fostered consistent Quality processes between the various divisions of clinical, pre-
clinical and manufacturing.
• Ensured that all quality based deliverables were complying with regulatory and quality
policies and procedures and timelines were met and observations were corrected.
• In collaboration with the Directory of Quality Assurance & Auditing, ensured that all the
appropriate SOPs were in place and that the appropriate level of training and
comprehensive had occurred.
Hospira, (Abbott Laboratories), McPherson, KS 9/10 - 2/11
Consultant QA (CAPA, OOS, Deviation and Investigation Specialist II)
• Performed a wide variety of activities pertaining to assuring compliance with applicable
regulatory requirements by conducting audits, training programs, data and documentation
reviews and analysis.
• Solutions to the exception reports through meetings and 3rd party teleconferencing
which led to the release of products such as Demerol Hydrochloride Injection,
Morphine sulfate inj and Vacomycin, Marcaine HCL, Erythromycin Lactobionate,
Heparing Sodium Inj, and Erythrocin Lactoblonate, etc.. , which products were released
to the 3rd parties with acceptable results.
• Delivered investigations and exception reports on time by executing each
investigation, as follows:
• Fishbone: Personnel, Methods, Equipment, Material, Historical, Miscellaneous.
• Risk Assessment: Scope, Objective, Assumption. Acceptance Criteria, Risk assessment,
Results/Recommendation.
• Root Cause: Machine, Material, Environment, Personnel, and Method/Design.
• Exception Report: Description (Event), Impact Assessment (Final Impact Assessment,
Investigation Detail, Time of Events), Historical Check/Investigation Analysis (Historical
Review, Investigation Analysis (personnel), Equipment/Instrument Assessment, Material,
Process/methods (Process Overview), Investigation Findings (Scope, Root Cause
Classification, Root cause description, Correction Type, Recommended Actions,
Summary and conclusions.
• The results of these investigations produced an exceptional improvement in all processes,
which reduced investigations by 86.25%.
• Worked closely with immediate supervisor to ascertain criteria that met company values
and profitability goals.
• Provided guidance and expertise to the Company, contract laboratories and Client
companies in matters relating to microbiology, quality control and stability studies.
• In order to effectively manage the stream of deviations being worked on:
• Interacted effectively with personnel (line personnel and management) when conducting
interviews.
Writeresult division of 3C Company, Inc. Kenilworth, NJ12/09 – 4/10
QA Manager GCP (Consultant)
• Executed a variety of studies for multiple Countries/Languages in accordance with the
protocols, SOPs, ICH-GCP and other regulations and guidelines.
• Created scripts for GCP and provided regular clinical status information to team
members.
• Developed SOPs under GCP guidelines and regulations.
• Executed a variety of activities at the company as needed
• Trained sites for clinical studies , Russia (Moscow), Japan (Tokyo), Colombia (Bogota),
Belgium (Amsterdam), France ( Paris) , etc..
• Performed and reported assigned GCP audits of studies including clinical investigators
sites, vendor/CROs, internal system/processes and clinical data and documents
• Provide input to the annual audit plan, schedule and auditors
• Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA
• Manage contract auditors as needed
• Support Health Authority inspection activities for domestic and international projects
• Support/provide quality system/GxP training to staff and develop/administer SOPs and
controlled FORMS, as well as, maintenance of the other controlled documents related to
the QA unit
• Maintain applicable QA systems and tracking mechanism for QA audits, CAPA, Quality
Systems, etc.
• Maintain high degree of knowledge of global industry expectations, GCP regulations and
provide GCP expert advice/guidance to staff in support of GxP Operations
• Perform additional QA responsibilities as directed by QA Director.
• Provided support, training, and a basis for the GCP Guideline and Regulation within the
organization.
• Enhanced protocols, making them more understandable to the clients.
• Improved profitability of the entire company team by approximately 42% for QA while
reducing the team by 12%.
• Grew a staff of job agents from its inception of 4 agents to 30 agents fully trained.
• Worked closely with immediate supervisor to ascertain criteria that met company values
and profitability goals.
• Traveled regionally 50% for Training purposes along the East Coast, to the Midwest and
Overseas.
Laureate Pharma, Inc., Princeton, NJ 2/05 – 3/09
Sr QA Compliance Specialist GCP and GMP
• Performed a wide variety of activities pertaining to assuring compliance with applicable
regulatory requirements by conducting audits, training programs, data and documentation
reviews and analysis.
• Proposed, planned and established systems and procedures to ensure product quality and
compliance with cGMPs.
• Perform and report assigned GCP audits of studies including clinical investigators sites,
vendor/CROs, internal system/processes and clinical data and documents
• Provide input to the annual audit plan, schedule and auditors
• Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA
• Manage contract auditors as needed
• Support Health Authority inspection activities for domestic and international projects
• Support/provide quality system/GxP training to staff and develop/administer SOPs and
controlled FORMS, as well as, maintenance of the other controlled documents related to
the QA unit
• Maintain applicable QA systems and tracking mechanism for QA audits, CAPA, Quality
Systems, etc.
• Maintain high degree of knowledge of global industry expectations, GCP regulations and
provide GCP expert advice/guidance to staff in support of GxP Operations
• Perform additional QA responsibilities as directed by QA Management.
• Organized a R &D team to determine the effectiveness and safety of an antibody cancer
drug for Prostate Cancer.
• Audited clinical investigator, TMFs, systems/process, document & vendor audits/
assessments.
• I was project mgr for the installation of the LIMS system by creating templates for the
QC, Micro, Material control (Raw Material), and F&F Departments.
• Managed 4 quality compliance individuals.
• All audits reviewed: SOP systems, data system, QC Department, Micro Dept, USP Dept,
Downstream Dept, QA system, Material control, R&D, Metrology System, Validation
System, GCP audits, GXP audits, GLP audits and Manufacturing audits.
• Audits performed annually as follows:
• 2005: 8 audits: internal 6 , and external 2
• 2006: 12 audits: internal 4, and external 8.
• 2007: 11 audits: internal 4, and external 7.
• 2008: 12 audits internal 4, and external 8.
• Evaluated non-conformances and assessed quality impact, recommended corrective
actions and followed up to ensure corrective actions implemented were effective.
• Provided QA presence in the Facility and Metrology areas by conducting compliance
walkthroughs and ensure compliance with FDA and other regulatory agency
requirements.
• Partnered with Facility and Metrology personnel to resolve compliance issues and ensure
a successful compliance profile.
• Ensured compliance observations associated with Laureate Pharma Facilities were
adequately addressed and completed on schedule.
• Reviewed standard operating procedures, validation protocols/reports, Work Orders and
Job Plans.
• Interacted with FDA and other regulatory agencies, as required.
• Performed qualitative and quantitative chemical analysis of raw materials.
• Coordinated testing responsibilities to ensure QA test support.
• Investigated testing abnormalities and implements CAPA.
• Validation of protocols, SOPs, Specifications, and test methods for all clients.
• Provided guidance and expertise to the Company, contract laboratories and Client
companies in matters relating to microbiology, quality control and stability studies.
• Coordinated and conducted periodic internal audits as well as audits of contract testing
laboratories, vendors, and other contract service providers as needed.
• Interfaced with other departments such as Manufacturing, Engineering, R&D,
Downstream processing, upstream processing and QC.
Bristol Myers-Squibb, Garden City, NY 1/01 – 12/04
Quality Control Scientist
• Focused on cross-functional operations to assure that the raw material department
operated within cGMP and SOP requirements. Reported any deviation from procedure to
appropriate personnel.
• Accomplished a 20% reduction of deviations (Q.I.R) by successfully performing research
of analytical methodologies to test formulations developed, according to USP, NF and EP.
• Strategically selected a panel of scientists to validate new product (600mg Sustiva) for
FDA approval.
• Resolved non-compliance of SOP by scientists for testing of production product resulting
in timely release of product.
• Led cross-functional team to confirm notebooks from other scientists to comply with
FDA regulations.
Orchid Biosciences (Formerly Lifecodes), Stamford, CT 2000-2001
Clinical Laboratory Analyst GCP
• Perform and report assigned GCP audits of studies including clinical investigators sites,
vendor/CROs, internal system/processes and clinical data and documents
• Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA
• Manage contract auditors as needed
• Support Health Authority inspection activities for domestic and international projects
• Support/provide quality system/GxP training to staff and develop/administer SOPs and
controlled FORMS, as well as, maintenance of the other controlled documents related to
the QA unit
• Maintain high degree of knowledge of global industry expectations, GCP regulations and
provide GCP expert advice/guidance to staff in support of GxP Operations.
• Accountable for all commercial activities associated with processing, analysis and
reporting of samples for DNA-based HLA typing for organ transplants.
• Managed comparative procedure and formulated DNA-micro-array analysis resulting in
an increase of 15% of donors' analysis.
Impath, The Cancer Company, New York, NY 1999 - 2000
Consultant, Quality Assurance GCP
• Ensured laboratory compliance resulting in reduction of laboratory investigation reports
by 30%.
• Perform and report assigned GCP audits of studies including clinical investigators sites,
vendor/CROs, internal system/processes and clinical data and documents
• Provide input to the annual audit plan, schedule and auditors
• Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA
• Manage contract auditors as needed
• Support Health Authority inspection activities for domestic and international projects
• Support/provide quality system/GxP training to staff and develop/administer SOPs and
controlled FORMS, as well as, maintenance of the other controlled documents related to
the QA unit
• Maintain applicable QA systems and tracking mechanism for QA audits, CAPA, Quality
Systems, etc.
• Maintain high degree of knowledge of global industry expectations, GCP regulations and
provide GCP expert advice/guidance to staff in support of GxP Operations.Ensured
laboratory compliance resulting in reduction of laboratory investigation reports by 30%.
• Developed and managed a secure protocol which increased production by $1.5 M
annually.
Pfizer, Brooklyn, NY 1993 - 1999
Associate Quality Control Scientist
• Initiated documentation of components and recorded all testing upon their completion
according to USP and EP, in compliance with FDA.
• Established product testing by increasing speed of testing process. (Zyrtec, Diflucan,
Zoloft, and Viagra.)
• Performed and documented quality control procedures of each production lot.
• Organized reference and internal standards for easy access.
• Reviewed all volumetric solution log books to assure that all safety requirements were
met.
EDUCATION
Adelphi University, Garden City, NY
MS, Biology
University of Rochester, Rochester, NY
BA, Biology
PROFESSIONAL DEVELOPMENT
CFPA
Certified Risk Management and Six Sigma "Black Belt”
CFPA
Certified Quality Auditor GMP
Brooklyn College
Salvatore Linguistic Award

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Ignace vallejo resume qa qc manager (2)

  • 1. IGNACE VALLEJO 718-946-0556 917-359-3028 525 Neptune Avenue, Brooklyn, New York 11224 ianvallejo@hotmail.com/ ianvallejo7@gmail.com www.linkedin.com/in/ignacevallejo/ SUMMARY • 15 years of experience in the Biotech/Pharmaceutical industry in Quality Assurance and Quality Control with extensive regulatory requirement knowledge • Conducted Product Investigations • Inspection of all product packaging to determine a non-negative product impact • Conducted both internal and external audits • Conducted monthly GMP training for all new Employees regardless of position • Delivered 100%, on time and before due date all reviews and releases of batch records • Initiated changes to S.O.P.'s to ensure compliance with all GMP's • 10 years of experience conducting GMP audits CROs & Vendors • Multiple European audits including France & Russia AREAS OF EXPERTISE • Fluent in Spanish, French, Italian and Portuguese • Knowledge of GCP, cGMP, GLP, GXP requirements • Certified Risk Management and Six Sigma "Black Belt" • Certified Quality Auditor GMP • Internal and external Audits • International audit experience: UK. France, Spain, Italy, Japan and Germany • National Audits: MA, CT, NJ, California, etc. • Release of Raw Material. • Batch reviews and release • Medical/Scientific Writing • QA/QC • TrackWise, LIMS system, and Isotrain. • Risk assessment, root cause, exception reports, CAPAs, deviation reports, investigation analysis and non conformance • 21 CFR part 211 guidelines EXPERIENCE Shire (Formerly Baxalta) 02/2016 – 07/2016 Consultant At Baxalta acquired by Shire, Atlanta/GA ( Covington) • Executed investigations in the Microbiology/Biochemistry Department and also have written SOP's on OOS in the pharmaceutical Industry. I was a member of the upper Management Team. • Verified Non-viable and viable contamination by presenting Metrics for every department through a power point presentation every other week.
  • 2. • Executed Qualification Audits during product qualification (PQ), for a pharmaceutical company that recently completed the construction of a multibillion dollar drug production plant facility containing departments for pre and post (PQ’s) Fractionation, Albumin, IG, Microbiology, Biochemistry, and Chemistry. VIRBAC , USA. 05/2014 – 12/2015 Consultant • Investigate deviations from QC department, this includes assessing the product impact, determining the root cause and implementing appropriate CAPA utilizing deviation data- base. (GMPs). • Ensured all assigned SOPs are compliant with internal procedure and FDA regulations. • Execute Internal and External Audit (Vendors, CRO, CMO and Major Pharmaceuticals) Glatt Air Pharmaceutical Services, Ramsey, NJ 2/14 - 4/14 Senior Compliance Specialist Consultant • Executed manufacturing investigations within the company for all products both liquid and solid. • Reviewed and approved internal audits of the facility. • Closed CAPAs and deviations before due date. • Planned International audits for the year in India and Germany. • Investigated and wrote investigations. • Performed internal/external audits, and trend investigations. • Maintained training records, and updated spreadsheets for investigations, CAPAs, monthly metrics, and GMP training. Novartis, Suffern, NY 6/12 - 7/13 Consultant QSC Deviation Investigator • Proposed, planned and established systems and procedures to ensure product quality and compliance with cGMPs. • Identify the root cause of a problem, then recommend and assure timely implementation of appropriate corrective actions. • Formulated solutions to the exception reports through meetings and 3rd party teleconferences leading to product release. • Identified true root cause of the incident. • Execute Internal and External Audit (Vendors, CRO, CMO and Major Pharmaceuticals) • Increased the effectiveness of the investigation, resulting in a lasting solution. Lonza Biologics - Portsmouth, NH 3/12 - 6/12 Consultant Deviation Writer • Investigated deviations from all departments, including assessment of product impact, determining the root cause and implementing appropriate CAPA utilizing TrackWise deviation database. (GMPs). • Ensured all assigned deviation investigations were compliant with internal procedure and FDA regulations. • Proposed solutions to the exception reports through meetings, 3rd party teleconferencing and investigations. • Delivered investigations and exception reports on time by executing each investigation, as follows: • Description, Purpose of the step, Investigation Summary, Root Cause, Impact product Quality, and Justification for no CAPA.
  • 3. • Audited and monitored the compliance status of company quality related operations and subcontractors. • Reviewed and approved internal and external manufacturing records, batch records, protocols, and analytical records. • Monitored and reviewed and /or approved CAPAs, deviations, amendments, investigations, out of specifications results and nonconformance. BARCUSA, Inc., Lake Success, NY 3/11 - 6/11 Quality Assurance Manager GCP Consultant • Executed clinical studies for multiple Global Pharmaceutical Companies in accordance with the protocols, SOPs, ICH-GCP and other regulations and guidelines. • Created scripts for GCP and provided regular clinical status information to team members (Project Managers, and CRA). • Served as the Single Point of Contact for selected CMOs, Pharma/Biotech, Pharmaceuticals and CRO to assess quality and compliance with procedures, quality agreements, Quality Systems Regulations. • Performed and reported assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents. • Provided input to the annual audit plan, schedule and auditors. • Prepared timely, well-written reports and obtained/evaluated audit responses while managing CAPAs. • Managed contract auditors as needed. • Supported Health Authority inspection activities for domestic and international projects. • Supported/provided quality system/GxP training to staff and developd/administered SOPs as well as controlled FORMS. • Maintained other controlled documents related to the QA unit and QA systems/tracking mechanism for QA audits, CAPA, Quality Systems, etc. • Maintained high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GxP Operations. • Assured that every test was performed as per protocols (Urine test, blood test, HIV test, Serum, etc.) • Developed SOPs under GCP guidelines and regulations. • Executed Internal & External Audits. • Conducted training On GCP and Good Documentation Practices. • Created and maintained a strong relationship with the leadership team and participated in all appropriate meetings and venues. • Worked with the Clinical and Pharmacovigilance Management and Quality Management team to ensure continuity. • Worked with the Director of Quality Assurance & Auditing to ensure an appropriate strategy and execution for audits through defined processes and practices. • Ensured visibility to and management of any noted deviations or deficiencies through trend and root cause analysis and worked with the appropriate team and internal QA Staff to implement a CAPA system and processes. • Fostered consistent Quality processes between the various divisions of clinical, pre- clinical and manufacturing. • Ensured that all quality based deliverables were complying with regulatory and quality policies and procedures and timelines were met and observations were corrected. • In collaboration with the Directory of Quality Assurance & Auditing, ensured that all the
  • 4. appropriate SOPs were in place and that the appropriate level of training and comprehensive had occurred. Hospira, (Abbott Laboratories), McPherson, KS 9/10 - 2/11 Consultant QA (CAPA, OOS, Deviation and Investigation Specialist II) • Performed a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits, training programs, data and documentation reviews and analysis. • Solutions to the exception reports through meetings and 3rd party teleconferencing which led to the release of products such as Demerol Hydrochloride Injection, Morphine sulfate inj and Vacomycin, Marcaine HCL, Erythromycin Lactobionate, Heparing Sodium Inj, and Erythrocin Lactoblonate, etc.. , which products were released to the 3rd parties with acceptable results. • Delivered investigations and exception reports on time by executing each investigation, as follows: • Fishbone: Personnel, Methods, Equipment, Material, Historical, Miscellaneous. • Risk Assessment: Scope, Objective, Assumption. Acceptance Criteria, Risk assessment, Results/Recommendation. • Root Cause: Machine, Material, Environment, Personnel, and Method/Design. • Exception Report: Description (Event), Impact Assessment (Final Impact Assessment, Investigation Detail, Time of Events), Historical Check/Investigation Analysis (Historical Review, Investigation Analysis (personnel), Equipment/Instrument Assessment, Material, Process/methods (Process Overview), Investigation Findings (Scope, Root Cause Classification, Root cause description, Correction Type, Recommended Actions, Summary and conclusions. • The results of these investigations produced an exceptional improvement in all processes, which reduced investigations by 86.25%. • Worked closely with immediate supervisor to ascertain criteria that met company values and profitability goals. • Provided guidance and expertise to the Company, contract laboratories and Client companies in matters relating to microbiology, quality control and stability studies. • In order to effectively manage the stream of deviations being worked on: • Interacted effectively with personnel (line personnel and management) when conducting interviews. Writeresult division of 3C Company, Inc. Kenilworth, NJ12/09 – 4/10 QA Manager GCP (Consultant) • Executed a variety of studies for multiple Countries/Languages in accordance with the protocols, SOPs, ICH-GCP and other regulations and guidelines. • Created scripts for GCP and provided regular clinical status information to team members. • Developed SOPs under GCP guidelines and regulations. • Executed a variety of activities at the company as needed • Trained sites for clinical studies , Russia (Moscow), Japan (Tokyo), Colombia (Bogota), Belgium (Amsterdam), France ( Paris) , etc.. • Performed and reported assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents • Provide input to the annual audit plan, schedule and auditors • Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA
  • 5. • Manage contract auditors as needed • Support Health Authority inspection activities for domestic and international projects • Support/provide quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit • Maintain applicable QA systems and tracking mechanism for QA audits, CAPA, Quality Systems, etc. • Maintain high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GxP Operations • Perform additional QA responsibilities as directed by QA Director. • Provided support, training, and a basis for the GCP Guideline and Regulation within the organization. • Enhanced protocols, making them more understandable to the clients. • Improved profitability of the entire company team by approximately 42% for QA while reducing the team by 12%. • Grew a staff of job agents from its inception of 4 agents to 30 agents fully trained. • Worked closely with immediate supervisor to ascertain criteria that met company values and profitability goals. • Traveled regionally 50% for Training purposes along the East Coast, to the Midwest and Overseas. Laureate Pharma, Inc., Princeton, NJ 2/05 – 3/09 Sr QA Compliance Specialist GCP and GMP • Performed a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits, training programs, data and documentation reviews and analysis. • Proposed, planned and established systems and procedures to ensure product quality and compliance with cGMPs. • Perform and report assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents • Provide input to the annual audit plan, schedule and auditors • Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA • Manage contract auditors as needed • Support Health Authority inspection activities for domestic and international projects • Support/provide quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit • Maintain applicable QA systems and tracking mechanism for QA audits, CAPA, Quality Systems, etc. • Maintain high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GxP Operations • Perform additional QA responsibilities as directed by QA Management. • Organized a R &D team to determine the effectiveness and safety of an antibody cancer drug for Prostate Cancer. • Audited clinical investigator, TMFs, systems/process, document & vendor audits/ assessments. • I was project mgr for the installation of the LIMS system by creating templates for the QC, Micro, Material control (Raw Material), and F&F Departments.
  • 6. • Managed 4 quality compliance individuals. • All audits reviewed: SOP systems, data system, QC Department, Micro Dept, USP Dept, Downstream Dept, QA system, Material control, R&D, Metrology System, Validation System, GCP audits, GXP audits, GLP audits and Manufacturing audits. • Audits performed annually as follows: • 2005: 8 audits: internal 6 , and external 2 • 2006: 12 audits: internal 4, and external 8. • 2007: 11 audits: internal 4, and external 7. • 2008: 12 audits internal 4, and external 8. • Evaluated non-conformances and assessed quality impact, recommended corrective actions and followed up to ensure corrective actions implemented were effective. • Provided QA presence in the Facility and Metrology areas by conducting compliance walkthroughs and ensure compliance with FDA and other regulatory agency requirements. • Partnered with Facility and Metrology personnel to resolve compliance issues and ensure a successful compliance profile. • Ensured compliance observations associated with Laureate Pharma Facilities were adequately addressed and completed on schedule. • Reviewed standard operating procedures, validation protocols/reports, Work Orders and Job Plans. • Interacted with FDA and other regulatory agencies, as required. • Performed qualitative and quantitative chemical analysis of raw materials. • Coordinated testing responsibilities to ensure QA test support. • Investigated testing abnormalities and implements CAPA. • Validation of protocols, SOPs, Specifications, and test methods for all clients. • Provided guidance and expertise to the Company, contract laboratories and Client companies in matters relating to microbiology, quality control and stability studies. • Coordinated and conducted periodic internal audits as well as audits of contract testing laboratories, vendors, and other contract service providers as needed. • Interfaced with other departments such as Manufacturing, Engineering, R&D, Downstream processing, upstream processing and QC. Bristol Myers-Squibb, Garden City, NY 1/01 – 12/04 Quality Control Scientist • Focused on cross-functional operations to assure that the raw material department operated within cGMP and SOP requirements. Reported any deviation from procedure to appropriate personnel. • Accomplished a 20% reduction of deviations (Q.I.R) by successfully performing research of analytical methodologies to test formulations developed, according to USP, NF and EP. • Strategically selected a panel of scientists to validate new product (600mg Sustiva) for FDA approval. • Resolved non-compliance of SOP by scientists for testing of production product resulting in timely release of product. • Led cross-functional team to confirm notebooks from other scientists to comply with FDA regulations. Orchid Biosciences (Formerly Lifecodes), Stamford, CT 2000-2001 Clinical Laboratory Analyst GCP • Perform and report assigned GCP audits of studies including clinical investigators sites,
  • 7. vendor/CROs, internal system/processes and clinical data and documents • Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA • Manage contract auditors as needed • Support Health Authority inspection activities for domestic and international projects • Support/provide quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit • Maintain high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GxP Operations. • Accountable for all commercial activities associated with processing, analysis and reporting of samples for DNA-based HLA typing for organ transplants. • Managed comparative procedure and formulated DNA-micro-array analysis resulting in an increase of 15% of donors' analysis. Impath, The Cancer Company, New York, NY 1999 - 2000 Consultant, Quality Assurance GCP • Ensured laboratory compliance resulting in reduction of laboratory investigation reports by 30%. • Perform and report assigned GCP audits of studies including clinical investigators sites, vendor/CROs, internal system/processes and clinical data and documents • Provide input to the annual audit plan, schedule and auditors • Prepare timely, well-written reports, obtain/evaluate audit responses and manage CAPA • Manage contract auditors as needed • Support Health Authority inspection activities for domestic and international projects • Support/provide quality system/GxP training to staff and develop/administer SOPs and controlled FORMS, as well as, maintenance of the other controlled documents related to the QA unit • Maintain applicable QA systems and tracking mechanism for QA audits, CAPA, Quality Systems, etc. • Maintain high degree of knowledge of global industry expectations, GCP regulations and provide GCP expert advice/guidance to staff in support of GxP Operations.Ensured laboratory compliance resulting in reduction of laboratory investigation reports by 30%. • Developed and managed a secure protocol which increased production by $1.5 M annually. Pfizer, Brooklyn, NY 1993 - 1999 Associate Quality Control Scientist • Initiated documentation of components and recorded all testing upon their completion according to USP and EP, in compliance with FDA. • Established product testing by increasing speed of testing process. (Zyrtec, Diflucan, Zoloft, and Viagra.) • Performed and documented quality control procedures of each production lot. • Organized reference and internal standards for easy access. • Reviewed all volumetric solution log books to assure that all safety requirements were met. EDUCATION Adelphi University, Garden City, NY MS, Biology
  • 8. University of Rochester, Rochester, NY BA, Biology PROFESSIONAL DEVELOPMENT CFPA Certified Risk Management and Six Sigma "Black Belt” CFPA Certified Quality Auditor GMP Brooklyn College Salvatore Linguistic Award