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Associate, Quality Assurance Specialist

2 months ago

Kansas City, Missouri, United States Catalent Inc Full time
Job Title: Associate, Quality Assurance

Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly motivated and detail-oriented Associate, Quality Assurance to join our team.

Job Summary:

The Associate, Quality Assurance will be responsible for quality oversight of manufacturing floor activities and associated in-process GMP records. This role will identify and participate in opportunities to improve processes, ensuring compliance with cGMPs, FDA guidelines, and internal SOPs.

Key Responsibilities:
  • Perform batch record review, cleaning log review, and complete monthly and daily facility audits
  • Ensure products are manufactured according to applicable cGMPs, FDA guidelines, and internal SOPs
  • Identify deviations during manufacturing and provide direction on the appropriate course of action
  • Review and approve batch documentation to adherence to SOPs and cGMPs
  • Participate in QA programs, procedures, and controls to ensure products conform to established standards and agency guidelines
Requirements:
  • High school diploma required with 3+ years Manufacturing/Quality Assurance experience in a GMP manufacturing environment
  • Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
  • Sufficient skills and knowledge in the use of computers and associated computer technology
Why Catalent:

Catalent offers a dynamic, fast-paced work environment with opportunities for career growth and development. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

We offer a competitive compensation package, including medical, dental, and vision benefits, 401K match, and tuition reimbursement. Join us in making a difference in the lives of patients worldwide.