Bristol Myers Squibb
SeniorSpecialist,QASterilityAssurance
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optimal for Senior candidates.
“Senior Specialist, QA Sterility Assurance at Bristol Myers Squibb. Skills: Sterility Assurance, Contamination control, Quality Assurance. Provide oversight for contamination control. Support New Product Introductions”
Industry & Context.
Interpret data; Understand problems; Critically assess; Critically review reports; Challenge technical conclusions
Ability to gown into cleanrooms
What They're Looking For.
Must Have
Ability to gown into cleanrooms, Advanced knowledge cGMP manufacturing, Ability to research policies, Ability to interpret data, Ability to critically review reports, Ability to work in fast-paced team, Able to work across functional groups, Ability to manage time, Early communication of delays, Ability to be flexible, Confident in making decisions, Curious and ability to think critically, Proficient computer skills, Bachelor's Degree in Microbiology, 4+ years relevant cGMP experience
Nice to Have
Knowledge of AI tools
What You'll Do.
Provide oversight for contamination control
Support New Product Introductions
Approve Environmental Monitoring Investigations
Support contamination investigations
Create technical documents
Revise technical documents
Author impact assessments
Participate in quality risk assessments
Support Contamination Control Strategy
Identify continuous improvement opportunities
Resolve Quality issues
Propose solutions for complex issues
Collaborate with cross-functional team members
Build relationships with partner departments
Represent department at meetings
Support environmental validations
Support Aseptic Processing Simulations
Participate in Aseptic Observer Program
Maintain compliance with learning plan
Support internal inspections
How You'll Work.
Team & Collaboration
Cross-functional team members; Partner departments; Cross-functional meetings
Communication Scope
Technical writing; Present technical data
Full Job Description
**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). **Position Summary:** The Senior Specialist for the QA Sterility Assurance group is an individual contributor responsible for areas of oversight and support of aspects of the site contamination control strategy, including New Product Introductions (NPI). The position will also be responsible for quality approvals, including Environmental Monitoring (EM) investigations. Will provide investigational support for contamination events, and for supporting contamination control risk assessments. This position reports to the Associate Director of Quality Assurance Sterility Assurance at Cell Therapy Manufacturing: Bothell. **Duties/Responsibilities:** * Quality oversight and support for programs such as cleaning and disinfection, gowning, access and flow, facility modifications, qualifications, disruptions, and shutdowns. * Quality oversight, support, and approval of Environmental Monitoring Excursion Investigations, including support for CAPA creation and Quality endorsement forums (Investigation Review Board & CAPA Review Board).
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