Senior Specialist, QA Sterility Assurance

Bristol Myers Squibb • Bothell, WA

12d • $92,290 - $111,837 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior