Sr. Specialist, Quality Assurance Drug Product Disposition Cell Therapy

Bristol Myers Squibb • Devens, MA

1d • $89,780 - $108,789 • Onsite

About The Position

The Sr. Specialist, Quality Assurance Drug Product Disposition, Devens Cell Therapy role is responsible for supporting quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This role will aid in the routine and timely release of drug product and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. This individual will support the Sunday-Wednesday shift and be responsible for working 4 days a week with 10 hour day shifts.

Requirements

• Minimum of 4 years of directly relevant experience in a regulated cGMP environment.
• B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
• Any combination of education, experience, and military service in line with recommendations above will be considered.

Nice To Haves

• Previous quality experience is preferred.

Responsibilities

• Preparing deliverables for product release within the inventory management system (SAP) or Cell Health Intelligence Platform (CHIP).
• Ensuring accurate and timely maintenance and review of batch record documentation.
• Authoring or reviewing departmental SOP’s and Work Practices.
• Developing and maintaining Standard Operating Procedures, training, and business processes supporting drug product disposition.
• Preparing documentation and deliverables per Standard Operating Procedures required for drug product disposition.
• Verifying accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.
• Performing the review of batch genealogy for all raw materials and components used in each batch to ensure that they are approved and released.
• May perform required updates to lot status in applicable quality systems.
• Works in electronic systems such as SAP, Learning Management, and Document Management systems.
• Coordinating with internal and external stakeholders to troubleshoot issues when required.
• Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
• Providing guidance to less experienced staff with atypical events during day-to-day operations.
• May own Quality System records such as deviations, CAPAs, or Change Controls.
• Performing Release for Infusion to calculate patient dosage.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior