Quality Assurance Specialist

2 days ago

Round Lake, Illinois, United States DivIHN Integration Inc Full time

Job Summary:

The Quality Lab Associate I position at DivIHN Integration Inc is a critical role that involves conducting chemical and physical analyses on pharmaceutical products throughout the manufacturing process. This includes raw materials, initial, in-process, and final products, as well as environmental monitoring programs.

Key Responsibilities:

  • Conduct critical chemical and physical analyses on pharmaceutical products using sophisticated laboratory instrumentation and computer systems.
  • Work under minimum supervision to maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
  • Participate in team functions to impact production, increase efficiency, solve problems, generate cost savings, and improve quality.
  • Perform laboratory and manufacturing audits as required, and audit and update plant SOPs as needed.
  • 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 SOPs and policies on cGMPs and safety, and maintain a clean, safe, and organized lab area.
  • Investigate deviations and write exception/OOL/OOS/OOT documents.
  • Support improvement projects and drive efficiency through the utilization of LEAN management principles.
  • Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues, and recommend solutions when issues arise.
  • Maintain and meet the highest standards in quality, customer service, and regulatory compliance.

Requirements:

  • Bachelor's degree in Chemistry or a Science-related degree with 6 months or more of experience.
  • Knowledge of Empower CDS and LIMS is preferred but not required.
  • Knowledge of GLP, cGMP requirements, and familiarity 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 pounds when required.
  • Occasional weekend work required.
  • Must not be color blind.

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