QA Specialist Deviation Investigator

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The QSAT (Quality Science and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The Deviation Investigator on the QSAT team is an individual contributor role responsible for investigating Notice of Event, Minor, Major, and Critical deviations to determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from reoccurring

This person will be a key player in the JuMP Quality Assurance team and a champion for quality priority principles and compliance within the JuMP organization.


Minimum of Bachelor's degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.

5 years of relevant cGMP experience. Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
Minimum of 4 years working within quality systems managing deviation and CAPA records.
Demonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.


Knowledge, Skills, and Abilities


Expertise in GMP compliance and FDA/EMA regulations.
Demonstrate excellence in written and verbal communication.
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Ability to anticipate and mitigate challenges.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1525708_EN

Updated: 2020-07-28 00:00:00.000 UTC

Location: Bothell,Washington

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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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