PROFILE * Strong background in Quality Assurance / Quality Control procedures with15 plus years of experience in the pharmaceutical and the biotech industry. * Experience in medical device, manufacturing, QC Lab, regulatory/QA functions in pharmaceutical, biologics sterile product manufacturing facility. Strong working knowledge of GMP, GLP, GCP, ICH & ISO guidelines. Excellent written, oral communication, organizational and interpersonal skill and attention to details. Analytical and technical trouble shooting skills. * Excellent understanding of clinical product release, stability studies, GMP, GLP, knowledge of cleanroom aseptic processing and supporting technologies, CAPA, quality plans, compliant handling, incoming inspection, calibration and preventive maintenance, bio-burden, creating DHF, DMR, DHR and/or Batch Records. Familiarity with Military Tests: MIL-I-23053D/1A, 15A, 5B and MIL-I-81765A, ASTM Standard Testing and Calibration.

Highlights:

• Preventive Maintenance
• Quality
• Quality Assurance
• Test
• Documentation
• Audit
• Distribution
• Good Laboratory Practices