We are seeking a Quality Assurance Specialist II, Raw Materials in Durham, NC, to oversee quality activities supporting biopharmaceutical production in a cGMP environment.
Responsibilities include leading risk assessments, authoring technical reports for raw materials, managing Change Controls, evaluating supplier notifications, conducting routine raw material testing, and supporting regulatory and internal audits.
Qualifications: Bachelor's degree in Life Sciences, at least 7 years in the pharma/biopharma industry, with 5+ years in Quality Control or Assurance. Strong experience with Change Controls, Deviations, CAPAs, and cGMP principles is essential.
Join a growing, innovative team committed to delivering life-changing therapies with a collaborative culture, advanced facilities, and opportunities for career development. This role does not offer sponsorship; US work eligibility required.