Quality Lab Associate Ii

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. 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. Must not be allergic to Penicillin and Cephalosporin 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 minimum supervision.
• Serve as mentor to Quality Laboratory Associate QLA I positions.
• Provide training and work direction for QLA I positions as required.
• 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.
• 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 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 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.

Skills:

Lab, quality control, HPLC, GC, chemistry, quality, GMP, GLP

Qualifications & Requirements:

• 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 System and LIMS is preferred but not required.
• Knowledge of GLP cGMP requirements and familiarity 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 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 2 or more years experience.

Experience Level:

Intermediate Level

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.