Associate, Quality Assurance Specialist

3 days ago


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

Catalent is a global pharmaceutical company that specializes 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 ensuring the quality of our products by overseeing the manufacturing process and reviewing documentation. This role will also involve identifying and participating in opportunities to improve processes.

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 Join Catalent:

Catalent offers a dynamic and fast-paced work environment with opportunities for career growth and professional 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 comprehensive benefits package, including medical, dental, and vision benefits, as well as a 401(k) plan and tuition reimbursement. Our company is dedicated to preserving and bettering lives, and we are seeking individuals who share our values and are passionate about making a difference.



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