Senior Specialist, Quality Assurance Shop Floor, Cell Therapy

Bristol Myers Squibb • Devens, MA

1d • Onsite

About The Position

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 will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position reports to the Shift Manager, Quality Assurance Shop Floor. This position works a rotating 2-3-2 Panama schedule (6am to 6pm) Day shift.

Requirements

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications.
• Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal skills and ability to present technical data effectively based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail oriented and task focused with ability to meet deadlines and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
• Pioneering mindset and ability to create innovative solutions.
• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with quality management systems
• Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP), etc.

Responsibilities

• Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & responding to complex issues independently and escalating critical issues to management
• May perform and document operational verification per approved procedures
• Develops, reviews and/ or approves temporary and non-routine procedure for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Provide quality oversight to non-routine maintenance work. Review and approve return to service plans
• Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans
• Own shift actions for departmental programs and propose improvements to programs.
• Participate in Gemba walks.
• Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies independently and escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.
• May own training curriculum and content .
• May present individual topics during audits as needed.
• Independently assess discrepancies for entry into quality system and approve deviations as applicable.
• May serve as quality subject matter expert for risk assessments, change controls, etc.
• Lead meetings and represent function at cross functional meetings.
• Share data/knowledge within and across team. Build & maintain strong relationships with partner functions
• May prioritize and assign tasks for the team

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: Mid Level