Quality Assurance Project
Resume:
GREGORY B. BURKE
Danbury, CT
********@****.***
PROFILE
Gregory Burke is an experienced quality assurance professional having specialized in consent decree remediation of
pharmaceutical and related biomedical research activities encompassed by the U.S. Good Manufacturing Practices,
and related multinational quality standards. Demonstrated record of eleven years GMP compliance experience. Strong
organizational and problem solving skills. An ability to design system improvements.
Gregory Burke has conducted audits and evaluations which assess the quality and integrity of data; evaluate
compliance with U.S. and multi-national regulatory obligations pertaining to food and drug quality, and document that
the organization was audited by an independent Quality Assurance body.
AREAS OF SERVICE
Food and Drug GMP evaluations/audits of Commercial, and Contract Clinical Supply and Food Factory Operations
Including
• Consent Decree Remediation
• Drug/food Product manufacturing
• Process & scale-up validations
• Drug Substance processing
• QA/QC systems evaluations
• Product complaint investigations
• GMP required records & reports.
• Labeling
• Storage and distribution
QUALITY ASSURANCE EXPERIENCE INCLUDES
• Close-out of site specific FDA consent decree observation and aligning site policies and procedures with
Corporate global policies
• Preplacement/ qualification audits of vendors, CMOs (Contract Manufacturing Organizations), raw material
suppliers, and contract laboratories
• "Due Diligence" assessments of Research and Development operations and research projects;
• Training of Clinical Research and Quality Assurance personnel
• Standard Operating Procedures (S.O.P.'s) evaluation and development
AREAS OF STRENGTH
Consent Decree remediation
GMP auditing of international and domestic facilities
Corporate Standards implementation
SOP writing
CGMP documentation requirements
Project coordination/prioritization
Optimizing laboratory/manufacturing and project efficiency
Communication
EXPERIENCE
UNILEVER, TRUMBULL, CT
U.S. Go-To-Market Quality Assurance Leader, May 2008- February 2009
- Develop companywide robust quality policies and procedures to ensure effective quality systems
within Unilever
- Oversee nationwide quality projects by coordinating and providing guidance to U.S. plant managers
on needed deliverables to ensure appropriate project completion
- Track and investigate regulatory citations, identify root cause, develop appropriate corrective and
preventive action
- Provide guidance to corporate and manufacturing facilities management on regulatory expectations
in a GMP environment
- Assist with GMP training for Unilver employees
- Ensure appropriate storage/retention for quality related documents & records
PENWEST PHARMACEUTICAL, PATTERSON, NY
Manager, Quality Assurance Audits, August 2006- March 2008
- Manage the compliance auditing and vendor qualification program for all raw materials, packaging
vendors and all contract manufacturing and testing facilities including GMP, GCP, GLP
- Manage the internal compliance auditing program
- Responsible for conducting internal and external GMP audits, preparing detailed audit reports
maintaining follow-up files, and establishing corrective action plans
- Facilitate client, FDA and other regulatory authority audits
- Handle problem solving and trouble shooting issues regarding GMP compliance
- Meet with managers, supervisors, plant associates and analysts to discuss and resolve issues
identified during audits
- Provide support to the GMP training program as required. Handle specialized projects and duties
pertaining the Quality Assurance Department.
- Manage the CAPA program.
- Assure that all corrective actions are implemented and verified in order to attain appropriate
quality/compliance standards and minimize risk.
- Obtain and maintain required Quality Agreements from vendors and contractors.
- Provide assistance and technical advice to achieve compliance and ensure inspection readiness.
- Identify and communicate information regarding significant quality risk to appropriate management.
- Contribute to development of quality strategy, objectives and goals, metrics, performance targets,
strategic initiatives.
WYETH VACCINES, PEARL RIVER, NY
Project Specialist IV, June 2005- July 2006
- Review and assess site SOPs to assure site compliance to Wyeth’s 27 quality system elements
(Corporate Standards).
- Create a project plan, design, and implement Corporate Standards at the Pearl River site in areas
identified as having to comply after review and assessment of site SOPs.
- Develop project scope, needed resources; risk assessment to project and communication based on
dialogue with project sponsors and functional area work teams.
- High level interaction/collaboration with corporate auditors/assessors who review and approve all
major phases of the project.
- Act as Pearl River liaison to corporate when corporate auditors conduct on-site audits/verification
of Wyeth’s quality systems.
- Generate responses to corporate audits/verification/reviews of quality systems.
- Assure appropriate documentation related to projects is being followed and maintained as per
department procedures.
- Report to site management status of project milestones to assure site monthly metrics for
sustainable compliance to Corporate Standards are being met.
- Identify quality systems needing improvement outside the corporate framework Optimizing system
process flow by revising SOPS to be more user-friendly, clearer, streamlining and consolidating
requirements to allow greater compliance.
- Assure site commitments (In Trackwise database) generated from corporate
audits/reviews/verifications are being completed by working with those assigned to commitment to
assure deliverables are met.
- Conduct and coordinate training on corporate related SOPs to assure final implementation of
corporate standards.
- Understanding of a multi-site operating framework and participation in multi-site projects.
- Departmental safety representative.
- Over 3 years experience with using Trackwise for CAPA and GXPharma for SOP review.
WYETH VACCINES, PEARL RIVER, NY
QC/QA Specialist III, November2002- May2005
- Responsible for monitoring potential GMP compliance issues within Quality Control Laboratories.
- Internal Auditor for Wyeth Vaccines Laboratories- Conduct internal audits of quality systems, lab
procedures, test methods, generate audit reports, make recommendations to improve compliance
and efficiency and follow up on corrective actions.
- Assist in resolving compliance issues related to consent decree items/FDA/EMEA/internal audits/
external audits/CAPA.
- Review and improve laboratory worksheets for the vaccines department. Enhance GMP compliance
by identifying areas where documentation can be improved.
- Assist in the review and improvement of test methods, SOP’s, monographs, and test protocols.
- Train the lab personnel on SOP’s and compliance topics. Facilitate monthly compliance meeting for
the laboratories
- Safety Representative for the Quality Control Department.
- Interact with different divisions/departments within the company to facilitate the resolution of
disagreements that allowed forward progress of projects to continue.
- Executed PQ Validation of LIMS system for Pearl River site. Working with LIMS team and the
laboratories in going “live” with LIMS.
- Assist with audits (Escort, runner) and walk-thrus of the labs for internal and external auditors
inspecting the Vaccines Laboratories.
- Housekeeping coordinator for all laboratory facilities in preparation for impending FDA, EMEA
inspections.
FOREST LABORATORIES, INC., INWOOD, NY
Quality Assurance Associate Level II, Manufacturing Operations, November 2000- November 2002
- Inspection of all manufacturing at various stages to assure compliance with GMP’s and SOP’s.
- Release of manufacturing areas, equipment, and materials prior to start of operation.
- Batch record review and release of batches for use.
- Sampling of water and air for microbiological testing.
- Conducting deviation investigations and generation of deviation reports.
- Surveillance of facility to assure compliance with GMP’s and SOP’s
NASTECH PHARMACEUTICAL COMPANY INC., HAUPPAUGE, NY
Clinical Research Associate, Level II July 2000-September 2000
- Assisted with the design and development of case report forms.
- Reviewed completed case report forms for completeness and correctness after clinical trials were
conducted.
- Reviewed and assisted the transcribing of source documents into case report forms.
- Responsible for record retention of clinical studies documentation such as protocols, amendments,
IRB approvals, 1571, informed consents, investigator’s brochure, and case report forms.
- Maintained record of patients enrolled and current status of patient visits for each protocol
- Maintained ongoing interaction with other members of the clinical team (Study monitors, Clinical
Director and Coordinator) to improve efficiency of the clinical trials; both the documentation and
working at hospital with patients, nurses, and the principle investigator.
Quality Assurance Associate, Level I October 1997- June 2000
- Review and approval of Specification/Analysis Reports for raw materials, packaging materials, label
materials, bulk in process drug product, finished drug product and stability data to meet in-house
and USP specifications.
- Overall maintenance of central files documentation including SOP system and change control system,
collaboration with other departments to draft and review SOPs, and coordination of SOP training
activities with department head.
- Generation of deviation and investigation reports, including product customer complaints.
- Conducted, drafted, and maintained annual product reviews.
- Audit of master batch records and executed batch records for manufacturing, primary and secondary
packaging of product and clinical manufacturing/production.
- Review of chromatography and microbial testing results of marketed product and raw materials.
- Assured Manufacturing/Packaging Department’s compliance to numerous validation protocols.
- Inspection and release of manufacturing and packaging operations at Nastech.
- In-Process inspection of filling and secondary packaging operations at Nastech.
- Liaison for Nastech involving contract packaging with CP Packaging, Jamesburg, NJ.
- Review and release of packaging records generated by CP Packaging for Nastech and inspection of
finished goods at CP Packaging.
EDUCATION/CERTIFICATION
STATE UNIVERSITY OF NEW YORK AT GENESEO.
Bachelor Of Arts, Biology, 1996
- Drug Development Certification, Temple University. Fall 2004
- American Society For Quality Certified Quality Auditor 2004-2010
- “Laboratory Controls And Compliance” IVT Training Course 08/04
- “How to Implement Lab GMP Compliance and Validation Requirements”
PTI Training Course 09/03.
Contact this candidate