QA Specialist - Drug Product Parenteral

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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.

Key responsibilities

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)

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com