Quality Lab Associate at Stefanini Group

• The Position encompasses the biological, chemical, and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.
• This is a third shift position but will be required to work on weekends to support training of analysts and to support projects and/or production, as required.
• A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.

• Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at client manufacturing facilities. Work under minimum supervision.
• Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data.
• Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
• Perform equipment maintenance and calibrations as required.
• Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records.
• Follow, understand and comply with client SOP's and policies on cGMP's and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas.
• Investigate deviations and write exception/OOL/OOS/OOT documents.
• Support improvement projects and drive efficiency through utilization of LEAN management principles (i/e/ 6S, Kaizens etc).
• Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise.
• Maintain and meet the highest standards in quality, customer service and regulatory compliance.
• Other projects as assigned.

• Knowledge of Empower CDS and LIMS is preferred but not required
• Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required
• Excellent communication (oral and written) and interpersonal skills
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a highly dynamic environment
• Ability to lift up to 50 pound when required
• Occasional weekend work required
• Must not be color blind
• Bachelors degree in Chemistry or Science related degree with 6 months or more of experience

Refcode: 58829_589