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QA Compliance / External Project Manager, Level II
REMOTE POSITION - Northeast area desired
Key responsibilities: Verification of the company's compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
Provide oversight and tracking for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
Review and approve GMP documentation and supporting documents, as required.
Perform review/release of batch disposition activities, as needed.
Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
GMP compliance and Part 11 compliance knowledge preferred.
Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic.
The ability to interface and communicate directly with customers, as required.
Experience with TrackWise, Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
3-5 Years Experience
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.