Bristol Myers Squibb QA Specialist - Drug Product (Parenteral) in New Brunswick, New Jersey
Scope of the role
Support parenteral drug product manufacturing area and responsible for quality release of drug products for human use.
Provides quality and compliance oversight to clinical drug product manufacturing ensuring compliance with company directives and governmental regulations.
Provides oversite and guidance to the Product Development manufacturing with respect to current GMP regulations
Perform quality related functions for the site such as Quality/GMP training and support of regulatory agency inspections.
Perform all product release activities, which include, but are not limited to, review of batch records, analytical tests results versus specifications, and other associated GMP documentation. Ensures that disposition decisions (release or reject) are entered into the inventory management system.
Review and approval of all documents related to the Quality System such as investigations into quality incidents & manufacturing deviations, corrective and preventative actions, procedural documents, to ensure conformance to cGMP, BMS standards and global regulatory requirements.
Supports the site compliance function during regulatory agency and third party inspections.
Provides guidance on quality issues to the Manufacturing group.
Provides guidance on quality issues to the project development teams (IDTs).
Assist in the authoring of Quality Agreements with contract vendors and collaboration partners.
Escalates immediately to the supervisor, any issues impacting product quality.
Professional experience and qualifications
Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy or biology or a related pharmaceutical science
Minimum of 7-9 years experience in pharmaceutical quality and/or operations at a site level, including 2-4 years experience in a regulated function
Experience within a QA/QC environment is an asset
Broad experience in the manufacturing of parenteral products
In-depth knowledge of cGMP regulations
Strong problem solving, interpersonal and organizational skills
Effective written and verbal communication skills
Computer literacy: Microsoft Office and SAP environment Trackwise®, PDLIMs, and other systems as required (eg DeltaV, Pilotclean)
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled