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Quality Assurance Specialist

2 months ago

St Louis, Missouri, United States Actalent Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a key member of our Quality Control Biochemistry Group, you will play a critical role in ensuring the quality and safety of biologic pharmaceuticals.

Key Responsibilities
  • Conduct Routine Testing: Perform compendial, purity, and impurity testing of pharmaceutical release, stability, and in-process samples using internally developed, qualified, and validated test methods.
  • Support Method Qualification: Assist in the qualification and validation of test methods for pharmaceutical concentration, purity, and impurity testing.
  • Prepare Regulatory Documents: Assist in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
  • Maintain Compliance: Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
Requirements
  • cGE Experience: Minimum of 1 year of cGE-icIEF experience in quality/analytical/pharmaceutical industry or similar experience.
  • GMP Knowledge: Working knowledge of GMP regulations in cGMP manufacturing environment.
  • Scientific Principles: Working knowledge of scientific principles for a wide range of analytical techniques.
Work Environment

This is a Friday-Monday role with a 10-hour shift. Must be flexible for 8-6pm, 10-8pm, and 12-9pm shifts.

This position involves bench work and requires a high level of attention to detail and organizational skills.