Senior Specialist, QC Support, Cell Therapy

Bristol Myers Squibb • Devens, MA

6d • $91,180 - $110,488

About The Position

The Senior Specialist manages the lifecycle activities of QC laboratory equipment and may serve as the QC equipment system owner. The role supports QC laboratories by coordinating equipment documentation, commissioning and decommissioning, qualification, calibration, maintenance, troubleshooting, and compliance activities. It also involves cross-functional collaboration, training and mentoring, and contributing to projects, investigations, change management, and continuous improvement.

Requirements

• Bachelor’s degree or equivalent; preferably in science. Netherlands applicants require MLO level 4.
• At least 4 years of relevant laboratory experience, or an equivalent combination of education and experience; preferably in a regulated environment.
• Ability to accurately and completely understand, follow, interpret, and apply global regulatory and cGMP requirements.
• Strong problem-solving ability, technical aptitude, and logical thinking.
• Ability to communicate effectively with peers, department management, and cross-functional peers about task status, roadblocks, and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Demonstrated technical writing skills.
• Demonstrated experience with equipment qualification and validation.

Nice To Haves

• Advanced degree.
• Advanced knowledge of computerized systems and enterprise applications such as SAP, ValGenesis, and Maximo.
• Working knowledge of data integrity principles.

Responsibilities

• Manage the lifecycle activities of QC laboratory equipment and potentially serve as the QC equipment system owner.
• Create equipment user requirements, validation protocols, and equipment-related documents.
• Collaborate with QC laboratories, Site Engineering, Facility Services, and other departments on the commissioning and decommissioning of laboratory equipment.
• Schedule, facilitate, and participate in qualification, calibration, maintenance, and repair of QC laboratory equipment, whether performed internally or by vendors.
• Maintain equipment records in accordance with GMP requirements and written procedures.
• Maintain the electronic equipment database, equipment logs, and equipment status metrics, and apply equipment status labels.
• Anticipate and perform routine troubleshooting and problem-solving with minimal guidance.
• Train and mentor others on equipment lifecycle processes and procedures, as applicable.
• Perform document revisions and related project, CAPA, deviation/investigation, change management, and continuous improvement activities.
• Review GMP documentation and records, including vendor-executed validation documents, for GDP adherence.
• Perform other tasks as required to support the QC laboratories.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Eligible U.S.-based exempt employees receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
• May be eligible for additional discretionary incentive cash and stock opportunities.

What This Job Offers

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