Quality Control Specialist II
4 days ago
We are seeking a highly skilled Quality Control Specialist II to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for supporting quality control testing operations at our Cell Therapy Center.
Key Responsibilities- Perform daily cGMP quality control laboratory microbiological testing activities, including in-process and final drug product microbial testing.
- Conduct environmental monitoring of cleanroom areas as scheduled.
- Perform data analysis and result reporting of microbiology assays to support product lot release.
- Ensure cGMP compliance in all activities.
- Support thorough cGMP investigations for out-of-specification test results.
- Perform environmental monitoring data trending.
- Support technical problem solving and product stability programs.
- Bachelor's degree in a relevant discipline, such as biological sciences.
- Minimum 3 years' experience in the pharmaceutical industry within a Quality Control role.
- Excellent communication and interpersonal skills.
- Ability to work in a fast-paced environment and manage multiple priorities.
- High level of ownership and accountability.
- Must be able to wear clean room attire and Personal Protective Equipment (PPE).
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% of a 10-hr day.
- Must be able to use near vision to view samples at close range.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 45 pounds.
- Clear and conceptual thinking ability.
- Excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
- Ability to handle work-related stress and multiple priorities simultaneously.
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