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Quality Lab Associate II

Company: Actalent
Location: Round Lake
Posted on: September 17, 2022

Job Description:

Description:Hours: 3rd shift: 10pm to 8:30amThe Quality Lab Associate II will be located at the Drug Delivery Chemistry Laboratories, Round Lake, IL. 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.Essential Duties and Responsibilities:* Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at Company manufacturing facilities. Work under minimum supervision.* Review and approve laboratory data to release batches and/or raw material for use.* 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 company SOPs and policies on cGMPs 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.This company develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, the company applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Arlington Heights , Quality Lab Associate II, Other , Round Lake, Illinois

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