Specialist, QC Analytical, B2 Shift, Cell Therapy

Position Summary

Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. May assist with method transfer, documentation, deviations, investigations, and continuous improvement efforts.

Duties/Responsibilities

• Perform routine testing of in-process, final product, and stability samples.
• Perform testing for method transfer/validation/verification.
• Perform data verification, data review and review of GMP documentation for general methods.
• May perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• Train analysts on general job duties.
• Perform other tasks as assigned.

Reporting Relationship

This position will report to QC management.

Qualifications

• Specific Knowledge, Skills, Abilities: Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Knowledge of LIMS, ELN and laboratory data analysis systems preferred. Problem-solving ability/mentality, technically adept and logical. Ability to communicate effectively with peers, department management and cross-functional peers. Experience with writing technical documents preferred. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Education/Experience/Licenses/Certifications: Bachelor's degree or equivalent required, preferably in science. Netherlands: Bachelor's degree / HLO in (bioanalytical) science preferred. MLO level 4 with equivalent combination of work experience may be considered. 2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).

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.
• 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.