Sr. Specialist, Quality Control Raw Materials (Method Transfer/Validation)
About The Position
Bristol Myers Squibb is seeking a Sr. Specialist, Quality Control Raw Materials with expertise in Method Transfer/Validation. This role involves performing method transfer, validation, verification, and routine testing of materials, as well as leading retain sample management activities. The position requires anticipating and performing routine troubleshooting and problem-solving with minimal guidance. Responsibilities include data verification, data review, and review of GMP documentation for both general and complex methods. The role also entails performing document revisions, project-related tasks, CAPA, deviation/investigation tasks, and continuous improvement efforts. Additionally, the specialist will train and mentor others on QC test methods, processes, and procedures. The company emphasizes challenging and meaningful work that transforms patients' lives and offers opportunities for career growth and development in a supportive culture.
Requirements
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements
- Demonstrated technical writing skills
- High problem-solving ability/mentality, technically adept and logical
- 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
- Bachelor’s degree or equivalent required, preferably in science
Nice To Haves
- Advanced degree preferred
- Advanced knowledge of LIMS and laboratory data analysis systems preferred
Responsibilities
- Perform method transfer/ validation/verification and routine testing of materials
- Lead retain sample management activities
- Anticipate and perform routine troubleshooting and problem solving with minimal guidance
- Perform data verification, data review and review of GMP documentation for general and complex methods
- Perform document revision, project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts
- Train and mentor others on QC test methods, processes, and procedures
- Perform other tasks as assigned
Benefits
- Medical coverage
- Pharmacy coverage
- Dental coverage
- Vision care
- BMS Well-Being Account
- BMS Living Life Better
- Employee Assistance Programs (EAP)
- 401(k) plan
- Short-term disability
- Long-term disability
- Life insurance
- Accident insurance
- Supplemental health insurance
- Business travel protection
- Personal liability protection
- Identity theft benefit
- Legal support
- Survivor support
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires (Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees)
- 3 optional holidays
- 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
- Annual Global Shutdown between Christmas and New Years Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
