Bristol Myers Squibb

SeniorSpecialist,QASterilityAssurance

$92–112k United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Problems you'll solve

Interpret data; Understand problems; Critically assess; Critically review reports; Challenge technical conclusions

Eligibility Requirements

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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