George A. Armstrong Jr.

St. Augustine, FL 904-***-**** adcp4e@r.postjobfree.com

www.linkedin.com/in/george-armstrong

QUALITY ASSURANCE AND COMPLIANCE LEADER

Innovative and strategic operations partner with extensive experience developing, implementing and executing initiatives to increase productivity, efficiency and reduce costs. Recognized for strong background in validated instrumental methods of analysis including GLP regulated laboratory. Hire, engage and retain top talent to achieve business objectives through coaching, mentoring and training. Core competencies:

GMP Quality Systems expert

Knowledgeable in current GMPs, GDPs, GLPs, 21 CFR 210, 211, 820, ISO 9001, ISO 13485, and ICH guidelines.

Data Validation

Product Complaint Management

Investigations

Audits

Metrics Analysis and Reporting and Key Performance Indicators (KPIs)

Corrective Actions / Preventive Actions (CAPA)

Technical writing, including audit reports, investigations, compliance standards, SOP and Work Instructions, Change Control,TrackWise Management Compliance

PROFESSIONAL EXPERIENCE

BRACCO DIAGNOSTICS INC., Cranbury, NJ April 2002 – April 2019

Manager, Quality Assurance

Managed complaints, change control, deviations / investigations and CAPA. Expertise in TrackWise. Calculated and reported quality metrics and trending of quality systems data and performance. Performed a variety of other QA related responsibilities including SOP writing, training, APR review, MBR review and product release, validation review and approval, and conducted 3rd party audits.

Contributed to project team meetings, QA quarterly review meetings, tech transfer meetings.

Chaired monthly meetings on Quality System metrics and reporting, including Change Control and CAPA status.

Provided SME support during regulatory inspections.

Recipient of 3 Excellence Awards.

WYETH-AYERST RESEARCH, Princeton, NJ March 1996 – January 2001

Scientist II – Biotransformation and Drug Disposition Research Facility Operations

Conducted cGLP regulated studies of new drug candidates using tandem GC / MS / MS and LC / MS / MS. In Research Facility Operations, managed all aspects of SOP preparation, revision, and distribution.

ADDITIONAL RELEVANT EXPERIENCE

ROY F. WESTON, Edison, NJ

Senior GC / MS Chemist, Organics – Response Engineering Analytical Contract (REAC), USEPA

Laboratory Supervisor

Manager Data Validation Group

ENVIROTECH RESEARCH, Edison, NJ

Laboratory Supervisor

MILITARY EXPERIENCE

US Military, Honorable Discharge

EDUCATION

Bachelor of Science – Environmental Science (BS),

Sigma Zeta National Science Honor Society, Marist College, Poughkeepsie, NY

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