David Mccafferty Email & Phone Number

Philadelphia, Pennsylvania

Marlton, NJ

Revenue Cycle Management

Review Manufacturing and Testing batch records in accordance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).Perform QA inspections in accordance with Code of Federal Regulations (CFR) and assure that any observations/deviations are properly investigated and explained.

Wrote and revised SOPs, Job Aids and Batch Records. Purchasing, validation and calibration of lab equipment.Utilized regulatory and quality guidelines to develop protocols for validation and recertification of equipment and Class 100, 10,000 and 100,000 compounding and filling rooms.Supervisor of all lab activities for second and third shift.

Strong knowledge of cGMPs, aseptic processing and 21 CFR 210 & 211.Trained and practiced in Lean Enterprise and Six Sigma methods to manufacturing.Managed release of products through LIMS.Implementation of disruption of controlled environment (DCE) reports.Managed Media Fill validation trials.

Liaison between Production and Microbiology for 2nd shift. Microbiologist responsible for quality control tests such as viable air/surface testing, non-viable air testing, bioburden, LAL, sterility, raw materials, growth promotion, HEPA certification and other test required by the FDA for the manufacturing of aseptically processed drugs.Support production.

Bachelor Of Science, Isat- Integrated Science And Technology

College of Integrated Science and Technology.

Master Of Business Administration (M.B.A.), Business Administration, Management And Operations