Quality Lab Associate

2 months ago

Round Lake, United States Rose International Full time

The client is seeking a candidate to perform biological, chemical, and physical analyses on pharmaceutical products throughout the manufacturing process, ensuring compliance with regulatory standards. The role involves operating advanced lab instruments, maintaining data integrity, and participating in efficiency improvement projects. The candidate must be able to work independently and within a team, handle occasional weekend shifts, and be comfortable with laboratory audits and equipment maintenance. Familiarity with GLP, cGMP, Empower CDS, and LIMS is preferred. The candidate must not be allergic to Penicillin, Cephalosporin, or related materials, and must not be color blind.

Education and/or Experience:

Bachelor's degree in Chemistry or Science related degree with 6 months or more of experience

Qualifications:

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

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 Baxter 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 Baxter 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
  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

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