Quality Assurance Specialist

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.

Principal Objective of the Position

Perform specific quality related functions to ensure facilities, utilities, equipment (including instruments and computerized systems) used in the manufacture, processing, testing, inspection, packaging, labeling, holding, storage, release, and

distribution of Active Pharmaceutical Ingredient (API) or Investigational Medicinal Product (IMP) intended for investigational and registrational purposes are commissioned, qualified, validated, and maintained in compliance with applicable cGMP regulations and BMS standards.

Key Responsibilities and Major Duties

Perform review and approval of initial commissioning, qualification, and validation lifecycle documents and subsequent changes.

Review and approval of periodic re-qualification assessments.

Review and approval of retirement and decommissioning plans, protocols and summary reports.

Review and approval of documentation related to change control.

Review documents related to Quality Systems such as SOPs.

Review Validation Master Plans (i.e. site, department and functional area/building).

Provide instruction and guidance on quality issues during regulatory agency inspections, quality event investigations, and CAPA discussions.

Participate in Quality Agreement process for Contract Service Providers.

Provide reports to management related to timely CAPA implementation or other issues, as requested.

Participate in Vendor/Contractors Qualification activities as requested.

Participate in internal audits of BMS GMP operations, and external audits of vendor/contractors.

Bring to the attention of management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.

Adherence to BMS core behaviors

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Degree/Certification/Licensure:

University graduate (science degree preferred)

Experience – Responsibility and minimum number of years ! Master of Science with 3 years experience or a Bachelor of Science with 5 years experience; including 3 years experience in regulated function.

Experience as a CQV, QA, and/or QC representative within Pharmaceutical/Drug

Device Manufacturing (API, Sterile, Non-Sterile or Biological products) or Medical Device Manufacturing or Laboratory environment.

Working knowledge in the following:

Process Control Systems

Process Equipment and Utilities

Laboratory Equipment and Instrumentation

Packaging and Labeling Equipment

Environmental Monitoring Systems

Supply Chain Systems

Demonstrated knowledge and experience in cGMP regulations.

Strong Interpersonal and organizational skills.

Demonstrated leadership skills.

Excellent written and verbal communications.

Proficiency with MS Office Suite.

Key Competencies – knowledge, skills, abilities, other:

Determine the acceptability of Commissioning, Qualification, and Validation procedures and activities.

Work as part of project team to evaluate the extent and impact of changes to GMP facilities, systems, equipment, processes and instruments.

Works with limited supervision.

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