QC Analyst 3
- Performs routine Bioanalytical testing and release of in-process, stability and REACT Final Product samples as scheduled
- Executes routine and non-routine analysis, including but not limited to raw materials, in-process items and finished product according to established operating procedures; may include:
- Flow Cytometry
- ELISA
- Kinetic Assays
- Cell Counting/Viability
- Visual Appearance
- Initiates and Supports Deviation/OOS investigations in MasterControl
- Initiates and Supports Action Item completion as assigned in MasterControl
- Initiates and Supports AQEM activities as assigned in Master Control
- Follows Test Methods (TSMs) Standard Operating Procedures (SOPs), Work Instructions (WRKs), and Protocols
- Authors originals, revisions, and training on TSMs, SOPs, WRKs, Test Forms, and Protocols
- Support QC Analytics with sample receipt from Manufacturing
- Trains and mentors incoming QC Analysts (all levels)
- Track and trend all QC Analytical testing performance of patient lot data along with critical reagent trending
- Maintain inventory levels in QC labs and coordinate material requests with Warehouse/Supply Chain
- Initiates, and participates in Change Control (MOC) management
- Authors/Initiates Aborted/Invalidated Assays in the QC Analytical Lab.
- Complete documentation accurately and in a timely manner
- Partakes in special projects on analytical methods and instrumentation problems related to execution of assays.
- Other duties as assigned
- Minimum of Bachelor’s Degree (or better) in chemistry, biochemistry, microbiology or related science
- 3-5 years’ experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry
- Knowledge of cGMP and understanding of GxP, good clinical practices, and FDA guidelines
- Familiarity with bioassays, and raw material test methods
- Knowledge of LIMS systems
- Deviation Handling
- Change Control Management
- OOS Investigation experience
- Subject Matter Expertise in assays relevant to the QC Labs
- Strong communication skills with the ability to interact with various individuals
- Detail-oriented with problem-solving and decision-making abilities
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