Inspection and Disposition of materials &#•••••; Strong Attention to Detail &#•••••; Generation and Proofreading Labels
&#•••••; Applied knowledge of cGMPs: ••••• CFR ••••• &#•••••; Able to work independently &#•••••; Follows Standard Operating Procedures
•••••/••••• •••••/••••• Imclone Systems Inc., Branchburg, NJ
Leading Biopharmaceutical manufacturer for cancer Drugs (Erbitux)
Quality Control Inspector
Inspecting incoming raw materials and components for commercial and clinical manufacturing under cGMP guidelines for pharmaceuticals
Aseptic sampling of chemicals in fume hood and class ••••• biosafety cabinet located in a class •••••,••••• clean room; sampling of gases for qualification and identity testing
Generation and verification of labels to identify dispositioned material status (released and rejected materials)
Inspecting finished product vials used in clinical trials; Assisting in the archival of critical documents
••••• ••••• Pharmaceutical Formulations, Inc., Edison, NJ
Leading generic pharmaceutical manufacturer
Quality Assurance Inspector ••••• •••••
Monitored conformance to current specifications for all packaged products and components.
Knowledge of all FDA, cGMP, and company SOP mandated guidelines.
Reviewed packaging orders for compliance to cGMP guidelines.
Coordinated inspection and release of all production components and finished products.
Rejected finished products and components that fail to comply with standards.
Proofread and approved printed materials for blister production.
Knowledge of counter machines, leak testers, laser inspectors, weight scales, tablet hardness testers, friabilators, micrometers, Mocon machines,
Extensive knowledge in proofreading labels, compression, encapsulation, printing, pharmacy, bulk packaging and coating operations.
Strong proficiency in establishing, managing, and facilitating the concept of Quality Assurance and Compliance; strong attention to detail and ability to work independently.
Line Operator ••••• •••••
Verified lot numbers, shipping codes, and expiration dates on product during production.
Verified all pertinent information is accurately logged on all paperwork.
Inspected and cleaned lings before production.
Promoted to QA Inspector in •••••
Government College of India: Masters Degree in Economics
Bachelors Degree in Education
Teaching Certificate: Five years teaching experience in India (English, Mathematics)
Certified in Microsoft Office: (New Jersey) •••••
Strong working knowledge of Oracle Applications/Database: (New Jersey ••••• •••••)