George Marshall

27775 Stansbury Blvd. Ste 239 Farmington Hills, MI 48334 Phone: (248) 207-4059
Email: mrpharmquality@yahoo.com http://www.linkedin.com/in/mrpharmquality
OBJECTIVE
A position in a company that could use my general experience, knowledge and hands on work ethic in any industry.
SUMMARY
Experience in Quality Assurance (QA) ranging from establishing QA systems in start-up companies, bringing new
companies through the IND and NDA phases through commercialization. Maintain and/or fine tune QA programs.
Total Quality Assurance Manager/Director responsibilities acquired/performed including, but not limited to:
* Developed, implemented and maintained the Quality System Program including policies, protocols and quality
standards to assure compliance with federal, state, local and corporate guidelines associated with the
pharmaceutical and related industries. GMP, GLP, Clinical Supplies, General GCP knowledge.
**Overseeing and directing the planning, creation, implementation and control of the quality system to ensure
product reliability, quality and efficacy.
* Reviewed and approved all Standard Operating Procedures (SOPs), Analytical Test Methods/Validation
(Protocols and Reports), Raw Material and Product Specifications, Sampling Plans, Batch Master Records,
Product Validations (Protocols and Reports) and Investigations (Deviations, NCMRs, Out-of-Specification
(OOS), Discrepancies, Variances...), recalls, audits Stability program and reports and returned goods.
* Primary responsibilities include-
** Evaluation of customer/product complaints creating and monitoring product complaint systems and response
to customers/patients, pharmacists, doctors as well as formal FDA complaints.
** Continuously monitored of complaint data to identify and correct adverse trends.
** Stability programs, including ongoing reports.
** Review of all data and dispositioned raw material, in-process and finished products.
** Review of environmental, microbiological, room and maintenance records and other ancillary data.
** Developing and overseeing CAPA/Corrective Action-Preventive Action and Complaint programs.
** Organizing, leading and/or performing internal and external audits of manufacturing and laboratory
operations/facilities including raw material suppliers according to Q7A guidelines.
* Provided leadership and/or coordinated QA requirements and guidelines for technology transfer from research
through process development to manufacturing and assured that these requirements were effectively
communicated to and coordinated with other functional areas.
* Supervised and/or provided support to QA, Documentation, Validation, Manufacturing, Metrology/Calibration,
Maintenance, Materials and Quality Control on special projects relating to compliance and quality issues.
* Developed and implemented programs, and committees, as well as provided expertise, with respect to
troubleshooting quality problems and quality improvement projects.
** Communicated quality issues, trends and reports to senior management in a timely manner.
* Defined cGMP training program for all personnel, included ongoing GMP training, updating GMP training,
special regulatory issues, warning letters from other companies and related guidelines and regulations.
* Interacted externally with professional, trade, regulatory agencies and interacted internally with technical,
regulatory and financial departments (budgeting).
* Represented company during client and FDA - GMP, PAI, and Complaint Audits
** Also OSHA, DEA and other investigations.
* Developed and implemented internal and external (vendor and laboratory) audit programs.
** Developed Vendor Certification Program, which included vendor screening and pre-evaluation.
* Reviewed all operational data and assisted in the preparation of CM & C section of regulatory submissions (e.g.
INDs, NDAs).
* QA representative to product development teams (PDTs), material review boards (MRBs), safety (OSHA) and
DEA and related committees.
* Actively interacted with Research and Development, Process Development, Regulatory Affairs, etc.
* Defined and justified the Quality Assurance budget including personnel and capital equipment.

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EXPERIENCE
Updating education 2004 – Current
Maintaining current via technical journals, school courses and seminars web seminars ((PDA) webinars,
webcasts, white papers, review of warning letters, etc.).
CARACO PHARMACEUTICAL LABORATORIES Ltd, Detroit, Michigan 10/2000-12/2003
Director Quality Assurance
* See "Quality Assurance Manager/Director: General responsibilities performed" (above).
* Assisted in passing FDA ‘for cause inspection’ after warning letter issued for January 2000 GMP inspection.
** Able to get Caraco “Released” from warning letter in March 2001.
* Developed Correction Action Plan, incorporating all reporting systems, including-Complaints, deviations,
incidents, OOS’s, TDRs, etc.
* Worked with Regulatory Affairs on developing the company safety and controlled substance programs.
* Performed GLP audits (21 CFR 58) of contract laboratory.
* Rewrote all Quality Assurance procedures. Wrote new procedures for Quality Assurance, environmental, training,
CAPA, maintenance, complaints and validation as well as assist all departments in updating their procedures.
Consulting/ while looking for permanent career 10/1998-9/2000
QA/QC Compliance Consulting [Irvine Analytical Laboratories HEM Pharmaceuticals, Expert Chemical
Analysis, Orgenics Corporation, Schering Plough, etc.]
* Setting up a contract-testing laboratory to be capable of analyzing samples in compliance with cGMP regulations
and to perform testing in compliance with federal and state EPA guidelines.
* Marketing company to local and state pharmaceutical companies.
* Developed Quality Assurance/Quality Control Manual to be used to apply for state EPA certification.
* Established initial Quality Assurance and Quality Control programs and systems from preclinical and Phase I,
through Phase III and Pre-Approval Inspection (PAI) for an existing product.
* Established base guidelines for QA program from research and development through Phase III.
* Performed extensive internal audits for Quality systems evaluations. Wrote extensive reports, which included
recommendations for corrective action(s).
* Developed quality programs, including QA and/or QC programs, updated or assessed existing programs.
* Drafted responses to FDA audit citations (483s), warning letters, regulatory letters, etc.
* Compared data in PMAs, NDAs, etc., to actual data records to assure sufficient and accuracy in regulatory
submissions.
SKYEPHARMA, PLC (formerly DEPOTECH CORPORATION), San Diego CA 5/1993-9/1998
Quality Assurance Manager
* See "Quality Assurance Manager/Director: General responsibilities performed" (above).
* Set up initial Quality Assurance and Quality Control programs and systems. {Start-up company}
* Prepared GLP program for in-house analytical testing and monitoring non-clinical study sites.
* Coordinated with the Clinical, QC, Regulatory and Manufacturing areas the testing, review, labeling and release
of clinical supplies.
AMVAX, INC. (Div. of NORTH AMERICAN VACCINE), Beltsville, MD 2/1987-3/1993
Director of Quality Assurance
* See "Quality Assurance Manager/Director: General responsibilities performed". (above)
* Set up Quality Assurance and Quality Control programs and systems. {Start-up company}
* Developed all procedures, specifications, batch records, Master Files, data collection forms etc. for QA, QC,
Manufacturing, Maintenance, etc.
* Assisted the company in reaching Phase II testing for vaccine.
MCLAS TECHNOLOGIES, INC., San Antonio, TX 2/1986-2/1987
Director of Quality Assurance/Quality Control
* See Quality Assurance Manager/Director: General responsibilities performed. (above)
* Created and implemented manufacturing, quality assurance, quality control, engineering purchasing and
warehousing programs.

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ABBOTT LABORATORIES, INC., Austin, Texas 6/1982-1/1986

Compliance Officer and Technical Service → Α sst. (Plant) QA Manager
* Developed, and performed in-depth internal regulatory audits.
* Participated in FDA and other government regulatory audits
* Coordinated and drafted responses to regulatory citations.
* Chaired the calibration/maintenance committee. (Streamlined calibration operation by 30%).
* Represented QA on Material Review Board (MRB) for dispositioning raw material, in-process, and final product,
which exceeded specifications, or were processed under batch record deviations.
* Reviewed, maintained and dispositioned product complaint files.
* Represented QA on the operations committee, which was responsible for the study and proposal of
recommendation of alternative operations, sampling, procedures, or other changes.
* Coordinated with Quality Engineering in review of AQLs, process control limits (SPC), sampling and evaluation
of raw material, in process, and final product trends.
ALCON LABORATORIES, INC., Fort Worth, Texas 9/1980-5/1982
Corporate GMP Specialist → Manager
* Responsibility to assure compliance of 6 domestic facilities and Puerto Rico facilities.
* Developed, maintained and implemented internal and external audit program.
* Assisted all departments and facilities in writing procedures and batch records for manufacturing, QA and QC.
* Developed cross-reference libraries for all Master Files, Master Batch Records, etc.
* Created and delivered lectures to corporate personnel with regard to the GMPs and the FDA.
* Interfaced with Regulatory Affairs with regard to FDA inspections.
* Assisted in the drafting of responses to FDA citations.
EDUCATION
Microbiology, Long Island University, Brooklyn, New York
30 Credits towards Master of Science degree
Fairleigh Dickinson University – Teaneck, New Jersey
20 credits towards M.S. Business (Business Management, Marketing, Accounting, Sales…)
B.S., Biology, City University of New York (Brooklyn College), Brooklyn, New York
Minors: Chemistry and Mathematics
Regents Scholarship, National Merit Scholarship
Research/Teaching Fellowship to Rutgers University
CONTINUING EDUCATION
Quality Control Management, Statistical Quality Control
Zenger-Miller "Frontline Leadership" seminars (Leadership, Management, Handling Stress...)
COMPUTER SKILLS
PC: MS Office, Visio, Access, and Project, Lotus, WordPerfect, Quattro Pro, etc.
PROFESSIONAL ASSOCIATIONS
Parenteral Drug Association (PDA)

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