Senior Analyst, Quality Control Microbiology – Microbial ID
About The Position
The Senior Quality Control Analyst in Microbial ID Team supports Iovance’s Cell Therapy Center (iCTC) quality control testing operations. The quality control testing programs include in-process and final drug product microbial testing such as Endotoxin, Gram Stain, Mycoplasma Testing, Microbial Identifications and Sterility techniques. This work shift is from Wednesday to Saturday. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the testing process is completed. Applicants must have experience in Microbial Identification.
Requirements
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
- Minimum eight (8) years of experience in the pharmaceutical industry within a Quality Control role
- Skills and knowledge in performing microbial ID testing
- Successfully interface with multi-disciplined teams
- Extremely detail-oriented with strong technical skills
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability
- Demonstrate a sense of urgency; ability to recognize time sensitivity.
Nice To Haves
- Experience with cell therapy products is a plus.
Responsibilities
- Lead Microbial Identification testing function
- Lead Microbial Banking related Initiatives
- Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
- Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
- Perform all activities for cGMP compliance.
- Lead thorough cGMP investigations for out-of-specification test results.
- Lead technical problem-solving.
- Operate at a consistent and exemplary efficiency level, producing high-quality and accurate results.
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
251-500 employees
