Senior Specialist, QA Sterility Assurance

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.

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).    
• Quality oversight and support for contamination investigations/CAPAs/effectiveness checks associated with, but not limited to environmental monitoring excursions, aseptic personnel qualification, aseptic operations, classified areas, utilities, and QC Microbiology testing related.
• Creation and Revision of technical documents (SOPs, Risk Assessments, Reports, Protocols, etc.), as requested. 
• Author impact assessments for low to moderate level site change controls, as requested. 
• Participate in quality risk assessments associated with contamination control program, owned by sterility assurance or stakeholder departments.  Assist with facilitation or serve as risk champion for department owned risk assessments.    
• Support the Contamination Control Strategy, Quality Initiatives, and Identify continuous improvement opportunities. Support execution of site/team improvement goals and projects related to environmental and contamination control programs.   
• Routinely recognize and resolve Quality issues; propose solutions for complex issues and work with management to resolve. 
• Ability to collaborate with cross-functional team members on projects related to contamination control programs. Build and maintain strong relationships with partner departments. 
• Lead meetings and represent department at cross-functional meetings sharing data and knowledge across team.
• Support New Product Introductions, environmental validations (Cleanroom Certifications, Environmental Performance Qualification, Aseptic Processing Simulations, and Airflow Visualization Studies), as needed.
• Participation in Aseptic Observer Program in manufacturing areas to ensure compliance with aseptic and cleanroom behaviors, gowning, cleaning, etc.
• Maintain compliance with assigned learning plan. 
• Support internal inspections as required. 
• Perform other tasks as assigned. 

Qualifications:

• Ability to gown into cleanrooms and perform work inside cleanrooms as assigned. 
• Strong verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy. 
• Advanced knowledge and experience with cGMP manufacturing, Quality and Compliance. 
• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.  Understanding how to navigate ambiguous situations.
• Ability to interpret data and results, understand problems with few variables and critically assess and provide feedback on proposed solution and required documentation. 
• Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with principles of contamination control and Quality risk management. 
• Ability to work in a fast-paced team environment and balance workload based on changing priorities. 
• Detail oriented and task focused with ability to meet deadlines and prioritize work. 
• Able to work across functional groups and teams to ensure requirements are met. 
• Ability to manage time to balance multiple priorities within designated timelines.
• Early communication of delays, challenges, and unexpected events. 
• Ability to be flexible, adapt quickly to change and shift priorities. 
• Self-motivated and contribute to a positive team environment. 
• Confident in making decisions for non-routine and minor issues.  
• Curious and ability to think critically to create innovative solutions. Raise issues and concerns, while providing reasonable, sound, and compliant options for path forward. 
• Proficient computer skills with knowledge of several digital tools like MS Office, Quickbase, Smartsheets, and ability to learn new software applications.  knowledge of AI tools. 

Education/Experience:

• Bachelor's Degree in Microbiology, Biology, STEM, or related science and 4+ of relevant cGMP experience, or equivalent combination of education and experience.
• Experience in Quality Control Microbiology, Contamination Control, and Quality Assurance functions in a cGMP manufacturing operation.
• Experience in FDA/EMA or similar regulation in biotechnology or cellular therapy field is preferred.
• Demonstrated ability to work cross-functionally to develop and maintain strong business partner relationships.
• Demonstrated experience with electronic systems and databases. 
• Demonstrated experience with root cause analysis and risk management tools such as 5-WHY, Human Error Prevention, Fishbone Analysis, FMEA, PrHA, etc.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

​Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.