Senior Specialist, QC Analytical, Cell Therapy
About The Position
Responsible for supporting quality control testing for in-process, final product, and stability samples, including data review and verification. The role performs method troubleshooting, training, and method transfer and validation. It also supports document revisions, projects, deviations and investigations, CAPA, and continuous improvement efforts. The schedule is Sunday through Wednesday, 1:30 p.m. to 11:30 p.m. The position reports to QC management and works in a laboratory setting, including a Biosafety Level 2 (BSL-2) environment. Employees must follow EHSS procedures and applicable safety practices.
Requirements
- Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability; 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.
- Ability to lift up to 20 lbs (9 kg) at floor and waist height, lift up to 10 lbs (4.5 kg) overhead, and push or maneuver carts to transport materials.
- Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
- Ability to independently don, doff, and wear required personal protective equipment for prolonged periods while performing laboratory work.
- Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
- Ability to work with dry ice, liquid nitrogen, and cryogenically cooled materials when required.
- Ability to use step stools while reaching and handling materials.
- Ability to work in a Biosafety Level 2 (BSL-2) environment and perform work safely in accordance with EHSS procedures.
Nice To Haves
- Advanced knowledge of LIMS, ELN, and laboratory data analysis systems.
Responsibilities
- Perform method transfer and validation, as well as routine testing of in-process, final product, and stability samples.
- Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
- Perform data verification and data review, and review GMP documentation for general and complex methods.
- Perform document revisions and tasks related to projects, CAPA, deviations, investigations, and continuous improvement efforts.
- Train and mentor others on QC test methods, processes, and procedures.
- Perform other tasks as assigned.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
- Paid time off arrangements that vary by employee eligibility and classification, including Flexible Time Off for eligible U.S.-based exempt employees or paid vacation for specified non-exempt and other employee groups.
- 11 paid company holidays; some employee groups also receive 3 optional holidays.
- Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, leaves of absence, and an annual Global Shutdown between Christmas Day and New Year's Day.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
