Department: Analytical Development
Description: Support analytical activities by performing analytical testing. Perform sampling, testing, calibration and qualification operations.
Essential Duties and Responsibilities:
- Sampling and analysis of materials, in-process, intermediates, APIs and FDPs
- Analysis of samples related to cleaning verification, reference standards, monitoring of critical utilities;
- Analysis of samples related to performance qualification and monitoring of critical utilities;
- Calibration and maintenance of instruments;
- Trending test results and investigating out of specification test results;
- Good record keeping, writing standard operating procedures and reports.
Education: BS or MS in Chemistry or relevant discipline
Experience: 5+ years of increasing responsibility and applicable experience in a pharmaceutical/biotechnology environment; excellent knowledge of lab operations and regulatory requirements are required, as are proficiency in analytical and technical skills; strong oral and written communication skills; ability to work both independently and as part of a team.
Specific Skills: Demonstrated experience with lab instrumentation, including HPLC, GC, Dissolution, Karl Fischer, IR spectrophotometry, TOC, conductivity, and wet chemistry tests; Familiarity with cleaning verification, stability studies, reference standard program is an asset; Formal cGMP training including knowledge of FDA and ICH guidelines.
Aerotek - 10 months ago
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