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Quality Assurance Specialist

2 months ago

Reston, Virginia, United States Kelly Full time

Job Summary:

Kelly is seeking a highly skilled Quality Assurance Specialist to join our team at one of our premier clients in the pharmaceutical industry.

Key Responsibilities:

  • Conduct critical chemical and physical analyses on raw materials, initial, in-process, and final products, and samples collected from environmental monitoring programs in the company's manufacturing facilities.
  • 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's 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 (e.g., 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.

Requirements:

  • 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 pounds when required.
  • Occasional weekend work required.
  • Must be able to distinguish between colors.

Education and/or Experience:

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