Specialist - QA Shop Floor

Summary The QA Specialist within the Quality Assurance Shop Floor organization provides quality oversight for routine clinical and commercial cell therapy operations, ensuring adherence to current Good Manufacturing Practices (cGMP). This role serves as a subject matter expert (SME) in cGMP, Good Documentation Practices (GDocP), and Data Integrity/ALCOA+ principles, supporting quality risk management and right‑first‑time execution on the Shop Floor at BMS Bothell. This position reports to QA Shop Floor Manager. 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. Schedule The routine working schedule for this role is Wednesday to Saturday, 13:30 – 00:00 hours (Quad 4). Duties and Responsibilities Perform real‑time review of executed batch records to ensure compliance with procedures; collaborate with manufacturing teams to resolve discrepancies. Observe manufacturing operations and identify departures from clean room behaviors, aseptic techniques and cGMP practices through QA Walkthroughs, Gemba and Process Observations. Own, review and approve moderate to complex operational documents such as Standard Operating Procedures (SOPs) and Work Instructions. Represent QA and execute tasks in continuous improvement initiatives, including Kaizen events, 5S activities, and cross‑functional Gemba. Lead deviation triage activities, ensuring quality events are assessed through a process‑ and risk‑based lens; drive timely and coordinate closure of NI/RCA events aligned with quality performance metrics. Education Bachelor's degree in STEM (Science, Technology, Engineering, and Math) field preferred. Associate's degree with an equivalent combination of education and work experience may be considered. Experience 3–4 years of GxP or equivalent experience in a regulated environment such as pharmaceuticals, medical devices, laboratory, biotechnology, or cell therapy manufacturing. Experience in batch record review, deviation management, and/or product disposition is preferred. Proficient in Microsoft Office applications (Word, Excel) and demonstrated proficiency in manufacturing systems such as MES, ERP (SAP), Deviation Management (Infinity) and Document Management (BMSDocs). Strong attention to detail with effective organizational, planning, and time management skills. Familiarity with quality risk management principles and ability to make sound, risk‑based decisions, escalating critical issues appropriately. Compensation Overview Bothell, WA, US: $38.42 – $46.55 per hour. 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. 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 Paid Time Off: US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays). 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. Additional time off 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. Equal Employment Opportunity BMS is committed to equal employment opportunity and is an affirmative action employer. This posting is subject to applicable laws and regulations concerning equal opportunity and accommodation. All applications are evaluated on a case‑by‑case basis. Job Code R1602866 – Specialist – QA Shop Floor #J-18808-Ljbffr Bristol Myers Squibb