Job Description
Job Summary:
- Â The QC Lab Analyst position works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze finished product samples prior to commercial release.
- This is a dynamic, growing lab within a growing manufacturing site with opportunity to learn new skills and to work cross-functionally.
Duties and Responsibilities:
- Performs, documents and record checks qualitative and quantitative assays on samples.
- The primary technologies in this lab are HPLC and dissolution.
- Interprets and evaluates data for accuracy, precision, trends, and potential GMP impact.
- Recommends and executes process improvements to continually improve laboratory performance.
- High productivity and the ability to multi-task coupled with a low error rate and attention to detail are critical characteristics of this position.
- Demonstrates flexibility/agility and engagement in a changing environment.
- The candidate is expected to display good laboratory technique to avoid cross-contamination or misidentification of samples.
- Ability to follow written procedures.
- May train others as skills and knowledge allow.
- Troubleshoot instrumentation as skills and knowledge allow.
- Participates in laboratory investigations as required.
- May participate in manufacturing QC support such as cleaning verification.
Education and Experience:
- AAS, BA/BS, or MS in Chemistry, Biochemistry, or related science preferred.
- Related experience in Quality Control is preferred but not required.
- Preferred experience includes GMP documentation, drug product formulation, in-plant laboratory, Incoming Inspection, SAP, LIMS, HPLC, Dissolution, use of Empower3.
Key characteristics of a successful candidate in this position:
- Willingness and ability to learn, ability to work in a team environment, and attention to detail.
- Job duties involve occasional lifting (less than 35 lbs.).
- Candidate must not be Cephalosporin/Penicillin sensitive.