Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm Rotating Shift Schedule)

Position Summary Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am‑6pm – Rotating 2‑3‑2 Panama Schedule). Works a rotating 2‑3‑2 Panama schedule (6am to 6pm). Report directly to the Shift Manager, QA Shop Floor. The QA Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including manufacturing, quality control laboratories, and warehouse operations. The Specialist ensures GxP compliance with BMS policies and global cGMP, serves as a Quality Representative, and owns quality decision making on the production floor, including deviation triage, alarm approval, and other Quality System Records. Key Responsibilities Provide routine QA on‑the‑floor oversight and triage unexpected events with manufacturing, quality labs, and supply chain. Interpret problems and prepare clear, concise communication for management and the group. Identify departures from approved procedures and address issues independently, escalating complex matters to senior members. Perform and document operational verification in the Manufacturing Execution System (MES) per approved procedures. Observe manufacturing operations and detect deviations from procedures, cleanroom behavior, and aseptic techniques. Provide quality oversight for pre‑planned return‑to‑service plans and conduct area walkthroughs to identify quality issues. Propose remediation actions and support implementation with area owners. Identify and propose improvements to programs, procedures, and practices. Review manufacturing batch records or QC testing records for compliance with approved procedures. Review and provide feedback on documents such as forms, logbooks, and procedures. Maintain compliance with an assigned learning plan and assist newer team members. Independently approve deviation records within the quality management system following quality risk management principles. Interpret technical conclusions of records/investigations and provide constructive feedback. Participate in quality and shift meetings. Build and maintain relationships with core partner functions and seek collaborative solutions. Champion quality culture and share data/knowledge within the team. Serve as SME for electronic systems such as BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc. Qualifications & Experience Action‑oriented with strong decision‑making, relationship‑building, problem‑solving, and analytical skills. Understanding and application of internal policies, procedures, and quality principles. Experience with quality processes: batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management. Ability to assess situations, diagnose problems, and propose practical solutions. Detail‑oriented, task‑focused, meeting deadlines and prioritizing assigned work. Capable of working in a fast‑paced team environment with changing priorities and limited information. Effective communication with cross‑functional peers and management through technical writing and verbal skills. Active listening skills and contribution to a positive team environment. Independent decision‑making based on data, with recognition of escalation points. Drive for continuous improvement of quality and operational processes. Experience working within pharmaceutical cleanroom environments. Proficiency with quality management systems for records handling (change control, product complaints, deviations, investigations, CAPA). Experience with GxP electronic systems such as MES for electronic batch records, ERP (SAP), laboratory information management systems, or electronic logbooks/forms. Proficient with digital tools (Microsoft Power Automate, Smartsheet, Tableau, etc.). Bachelor's degree in a STEM field; high school diploma or associate’s degree with equivalent education and work experience considered. Minimum 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience. Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. Compensation Overview Devens, MA, US: $40.16 – $48.67 per hour. The starting compensation range is for full‑time employees and may include additional incentive cash and stock opportunities. Final individual compensation will be based on demonstrated experience. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs. Financial Well‑being: 401(k) plan, disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability, 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. Non‑Exempt and hourly employees receive 160 hours annual paid vacation with manager approval, 11 national holidays, and 3 optional holidays (locations vary). Additional paid sick time, unpaid volunteer days, summer hours flexibility, and other leave options per eligibility. Annual Global Shutdown between Christmas and New Years Day for eligible employees. Equal Opportunity: BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. #J-18808-Ljbffr Bristol Myers Squibb