Chemist II (2nd Shift)
- 50% -- Test and analyze OTC product, non-OTC product, and other material as assigned. Use UPLC/HPLC and ICP-OES instruments and related software to acquire, process, and document test results. Conform to all applicable cGMP and safety guidelines.
- 10% -- Troubleshoot instrumentation issues and out-of-specification (OOS) or out-of-trend results. Use clear reasoning to develop and evaluate investigation hypotheses, results, and any corrective and/or preventative actions needed. Assist in evaluating and troubleshooting third-party OOS investigations.
- 10% -- Oversee and provide guidance on daily activities for Chemist I and entry-level staff (lab technicians and interns) regarding best practices for test methods, troubleshooting instruments, and interpreting test results. Assist in the assignment of workload and disposition of tested materials.
- 10% -- Document results following laboratory guidelines and cGMP practices. Clearly, concisely, and logically communicate issues and outcomes to management in a timely fashion.
- 10% -- Track and trend stability results.
- 5% -- Assist in training of Chemist I and entry-level staff.
- 5% -- Perform other tasks as assigned, ensuring smooth laboratory workflow and daily operations.
- Must have working knowledge of analytical techniques (conventional and instrumental, including chromatography and emission spectrometry) and all instrumentation typically found in a well-equipped pharmaceutical analysis lab.
- Must have working knowledge of Microsoft Office (Word and Excel; Access a plus). Waters Empower experience a plus.
- Must have knowledge of OTC and FDA guidelines and applied knowledge of GMPs.
- Must have demonstrated problem solving skills with ability to conduct root cause analysis in laboratory investigations.
- Must have excellent oral & written communication skills and strong organizational skills.
- Must be able to work additional time as needed.
- Experience in high throughput lab a plus.
- Cosmetic and pharmaceutical experience a plus.
- SAP skills and experience a plus.
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