Quality Lab Associate Iii (2 Openings)

This is a first shift position but will be required to work on weekends to support training of analysts and to support projects and/or production, as required.

Summary
The Position encompasses 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.
The candidate must not be allergic to Penicillin, Cephalosporins, or their related products and /or materials.
Essential Duties & Responsibilities
Conduct critical chemical and physical analysis on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at the Round Lake manufacturing facility.
Work under minimal to no supervision.
Serve as mentor to Quality Laboratory Associate (QLA) I and II positions.
Provide training and work direction for new hires.
Perform review of test data, which includes overall documentation practices.
Perform release functions in LIMS or other computerized systems.
Use sophisticated laboratory instrumentation (e.g., HPLC, GC) and computer systems to collect and record data.
Be a Subject Matter Expert (SME) on equipment and know how to troubleshoot issues.
Perform advanced chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
Complete all testing, including special project / protocol testing in a timely and appropriate manner.
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, Kaizen, 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.
Qualifications
Must have good oral and written communication skills, strong analytical skills and be detail oriented.
Knowledge of current Good Manufacturing Practices is preferred.
Advanced laboratory skills with basic knowledge of statistical methods.
Strong technical problem solving skills.
Ability to handle multiple tasks concurrently, and in a timely fashion.
Knowledge of Empower Chromatography Data Systems and LIMS is preferred but not required.
Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required.
Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation, and task completion.
Ability to work independently and as part of a team, is self-motivated, demonstrates adaptability, and possesses a positive attitude in a highly dynamic environment.
Ability to lift up to 50 pounds when required.
Occasional weekend work required.
Must not be color blind.
Must not be allergic to penicillin or cephalosporin drugs.
Education
Bachelor degree in Chemistry or physical science with 5 or more years of experience.