Quality Control Analyst II
Role Overview
Perform routine and non-routine analytical chemistry assays for raw materials, in-process samples, finished APIs, and stability samples.
Participate in special projects, method development and transfers, and cleaning study qualifications.
Key Skills for This Role
Full Job Posting
Role overview
Perform routine and non-routine analytical chemistry assays for raw materials, in-process samples, finished APIs, and stability samples.
Participate in special projects, method development and transfers, and cleaning study qualifications.
Responsibilities
- Test incoming, in-process, final, and stability samples using laboratory equipment including balances, pipettes, pH meters, UV/Visible spectrophotometers, and TOC analyzers.
- Perform HPLC, GC, UPLC, wet chemistry, analytical chemistry assays, and raw-material testing or sampling.
- Maintain and calibrate QC instruments and general laboratory equipment; maintain laboratory housekeeping and audit readiness.
- Perform or assist with method qualification, transfer, validation, and development, as well as cleaning validation studies.
- Assist with new equipment and process evaluations, QC data review, and management summaries.
- Support QC investigations for out-of-specification results, deviations, and CAPAs.
- Back up sample receipt, testing coordination, shipment, tracking, result distribution, and closure.
Qualifications
- Bachelor’s degree in Chemistry or a relevant field and 3 years of related experience, or a master’s degree in Chemistry or a relevant field and 1 year of related experience.
- Must pass a background check and drug screen; occupational health screening may be required.
Preferred techniques
- Preferred experience includes SEC-HPLC/UPLC, electrophoretic techniques such as CE-SDS or cIEF, ligand-binding assays such as ELISA or Octet/BLI, and qPCR-based assays.
- Other preferred techniques include UV/Vis, mBCA, pH, conductivity, osmolality, wet chemistry, and product quality assessments.
Pay
- Pay range is $80,000–$85,000 per year.
Benefits
- Benefits include benefit options, paid training, vacation and holidays, education reimbursement, a matching 401(k), and a learning platform.
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