Aseptic Manufacturing Expert
3 days ago
This role involves exercising judgment within generally defined practices and policies when selecting methods and techniques for obtaining solutions. You will also have the opportunity to work independently and as part of a team to achieve goals and objectives. Other responsibilities include prioritizing, scheduling, and managing multiple projects and resources; ensuring the safe release of cellular products according to company and/or client procedures and requirements; promoting compliance with applicable CGMP and GTP regulations and company SOPs; and providing input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
Requirements:
- BS in biological sciences or other relevant field of study
- 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics.
- Working knowledge and technical understanding of aseptic manufacture of biologics
- Understanding of quality system applications
- Experience in both clinical and commercial manufacturing is preferred.
- Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc.
- Computer skills (Microsoft Office, Outlook)
Salary: $90,000 - $120,000 per year
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