Marshall R. Martin
Compliance Consultant @Oxford Consulting
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WORK HISTORY
Compliance Consultant @Oxford Consulting
Cornelia, GE
Reviewed Physical and Chemical testing data from finished products samples to ensure compliance with all specifications. Signed off the documents as data reviewer.Approved as a Supervisor to sign off documents for finished products release when the data review was done by someone else.Received Samples from Manufacturing and reviewed the lot numbers on the samples against the lot numbers on the documents to ensure they were correct. Then checked the samples into the Physical and Chemical laboratories for testing.Trained someone to perform data review.
EDUCATION
North Carolina State University - College of Management
MBA, Management and Finance
Wofford College
B.S., Chemistry
SKILLS
ABOUT MARSHALL R. MARTIN
I am a Quality Systems Consultant with 15 years pharmaceutical industry experience, including 10 years in management roles, and 9 years in biological drug products. I have a strong understanding of CMO business models and operations. Specialties include parenteral, solid-dosage and dermatological drug delivery mechanisms. I am especially skilled at designing and implementing corrective action plans, authoring process-driven SOPs, and conducting gap analyses to help companies achieve a higher level of compliance. My capabilities include: Operational efficiencies (design and implementation). Authoring testing protocols and data interpretation. Leading laboratory investigations, identifying root causes, and authoring technical reports to summarize investigation findings. Designing corrective action plans that address the true root causes of OOS test results and regulatory agency observations. Conducting gap analyses to identify compliance deficiencies within Quality Systems. Managing regulatory agency audits within QC laboratories. Validation and Qualification of Laboratory equipment for GMP usage. Coaching and mentoring analysts at all skill levels. Talent management for QC laboratories. Building partnerships across QC, Validation, QA, and Manufacturing teams. Customizing training programs that ensure consistency and adherence to cGMP. Conducting ROI analyses for capital asset purchasing Technical and Quality Systems skills: Agilent 1100/1200 HPLC instrument operations, Agilent Chemstation software, Empower Data Acquisition software, Trackwise version 8.3.2, LABWARE-LIMS, Microsoft Office, Microsoft Project
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