Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA

Bristol-Myers Squibb • Devens, MA

127d • $83,540 - $101,228 • Hybrid

About The Position

The Specialist, QA Shop Floor, Cell Therapy will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position involves working in shifts from 6pm to 6am, with rotating scheduling including holidays and weekends, onsite.

Requirements

• Bachelor's degree in STEM field.
• High school diploma or associate's degree with equivalent combination of education and work experience is considered.
• 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
• Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions.
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.
• Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.
• Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.
• Active listening skills to understand diverse working perspectives.

Nice To Haves

• Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.
• Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
• Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.
• Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
• Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.
• Provide quality oversight for pre-planned return to service plans.
• Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.
• Identify and propose improvements to programs, procedures, and practices.
• Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.
• Review and provide feedback on documents such as forms, logbooks, and procedures.
• Maintain compliance with assigned learning plan.
• Provide integration support of newer team members.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.
• Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
• Participate in quality and shift meetings.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Share data/knowledge within team by acting as a champion for quality-culture.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree