Quality Assurance Senior Specialist, Site Support

Bristol Myers Squibb • Devens, MA

9d

About The Position

Support Devens site through review and approval of investigations and change controls. Provide Quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science and Technology, Master Data and Site Engineering programs. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for and hosting of regulatory and customer audits.

Requirements

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity, LES, Vitalize, Maximo, Vault, and Syncade desirable.
• Experience working in a team-based environment with a diverse group of people.

Responsibilities

• Provides quality support to Devens Site through quality review and approval of deviations or change controls.
• Supports technical transfer sub-teams and the review and approval of technology transfer documentation
• Support automation forums.
• Provide review and approval of automation change management.
• May lead automation change management forums.
• Support review of the cell bank disposition program.
• May track and review deliverables.
• May support projects and incoming transfers for cell banking operations.
• Review and approve Master Data for SAP and Syncade in support of tech transfer and projects.
• Review and approve Maximo work orders, OOTs, extensions for PMs and Cals.
• May participate in projects with limited decision-making.
• May provide quality support for Manufacturing Science and Technology and Validation reports as well as periodic assessments.
• Participates as requested in the response team for audits and inspections by world health authorities.
• Represents QA in cross functional meetings.
• Makes sound decisions by coordinating with higher level QA personnel and exercising judgment within generally defined practices and policies.
• Applies appropriate notification to management as appropriate.
• Receives assignments which require the application of a defined process to complete the assignment. As such, specific assignments are allocated based upon the recipient’s demonstrated capabilities with the degree of supervisory attention determined accordingly.

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
• Number of Employees: 5,001-10,000 employees