Quality Assurance (QA) Specialist

Job Responsibilities:

In collaboration with Process R&D, and other Pharmaceutical Development
functions, ensure compliance with global cGMP regulations and company
procedures for the production of investigational medicinal products. Schedules
and performs review of API Active Pharmaceutical Ingredient and intermediate
manufacturing batch records, analytical data, and other associated
documentation, and approves API for clinical use. Participates in a team
environment to investigations into quality incidents associated with production
of API and intermediates. Tracks incident investigations and associated
corrective and preventive actions. Reviews SOPs, other procedural documents as
needed, and provides GMP training to internal customers as required. Provides
guidance on CGMP issues, interpretation of the regulations and maintains
awareness of industry trends.

Job Requirements/Education:

A B.S. with 7 to 9 years of experience or M.S. with 4 to 6 years, including 2
to 4 years experience in a FDA regulated function. Requires knowledge and
understanding of cGMP regulations as they pertain to drug substance and
production activities. In-depth knowledge of development and production of drug
substance is critical. Experience in a QA organization or in a clinical
production environment is a plus. Strong computer skills and the ability to
learn new software applications Trackwise, SAP, DeltaV, LIMS are critical.
Excellent judgment, strong organizational and communication skills and an
ability to handle multiple tasks are key attributes of a successful candidate.
The ability to interact constructively in a team approach to problem solving is
important.

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D