Job Title: Quality Control Associate III
FLSA Status: Non-Exempt
Job Number: 04551009
Department: Quality Control
Description:
Support Lorcaserin related analytical activities by performing test method transfers, analytical testing related to lorcaserin. Support Manufacturing by performing release testing of materials as well as maintenance of validation and documentation as it relates to Quality Control programs.
Essential Duties and Responsibilities:
- Sampling and analysis of raw materials, in-process materials, 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.
- Makes recommendations for major changes in procedures for SOPs, protocols and reports pertaining to QC project functions and GMP compliance in light of technical progress and historical results when necessary.
- Good record keeping, writing standard operating procedures and reports.
Job Requirements:
Education: BS or MS in Chemistry or relevant discipline
Experience: 5 + years of increasing responsibility and applicable QC 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
Supervisory Responsibilities: None
Physical Demands/Work Environment: Some evening/weekend may be required to support manufacturing on occasion. Ability to handle hazardous materials. Ability to lift 30 lbs.
