Senior Quality Assurance Specialist

7 days ago


Durham, North Carolina, United States Cambrex High Point Full time
Job Summary

Cambrex High Point is seeking a highly skilled Quality Assurance Specialist II to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products and services.

Key Responsibilities:

  • Perform independent quality evaluations and releases of support documentation, materials, products, equipment, and/or facilities.
  • Ensure all testing/manufacturing was performed per approved SOPs/methods/protocols and comply with specifications.
  • Participate in department/client meetings, collaborate, and cooperate to achieve cross-functional improvements and business goals.
  • Ability to participate in internal, client and/or regulatory audits.
  • Basic understanding of root cause analysis tools, CAPA and able to support quality events.

Requirements:

  • Related BA/BS, required.
  • 2-4 years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance.
  • Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.

About Cambrex High Point:

Cambrex High Point is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. We are committed to providing a safe and productive work environment and are an Equal Opportunity / Affirmative Action employer.



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