Associate Specialist QA

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.

This is a Wed - Sat AM Shift - 7a - 5:30p

PURPOSE AND SCOPE OF POSITION:

The Quality Associate Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (JuMP). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports JuMP’s release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at JuMP with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment.

The primary focus of the QA Associate Specialist role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at JuMP by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

Bachelor’s degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.

Experience

3-5 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.

Hands-on experience with batch record review and product disposition is preferred.

Knowledge, Skills, and Abilities

Strong computer skills with Word and Excel and other electronic manufacturing systems.

Detail oriented team player with effective planning, organization and execution skills.

Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.

Good organization and time management skills.

Ability to work in a high paced team environment.

Strong written and verbal skills.

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