Vacancy expired!
Piper Companies is currently seeking a QA Associate for an innovative Biotechnology company focused in research in the Baltimore, MD area.
Responsibilities for the QA Associate include:- Review and approve executed cGMP documentation and other documents relating to cGMP activities
- Prepare, execute and follow-up of internal and external vendor/supplier, service audits
- Initiate new SOPs and/or revise existing SOPs as needed
- Initiation, tracking and closure of Deviations, Change Controls, CAPAs and Out of Specification events
- Review and approval of CGMP (equipment, inventory etc.) logbooks
- Review, approval and release of raw materials for use in CGMP manufacturing and testing
- Perform line/room clearances
- When appropriate, assist in FDA inspections regarding regulated activities
- Stay current with CFR and/or FDA guidance documents and EU regulations to ensure that compliance policies are up to date
- Occasional weekend and evening work will be required
- Assist in product label preparation
- Present cGMP training programs
- Participate as QA floor representative during manufacturing operations
- Travel between two CEL-SCI CGMP facilities (North Baltimore and Elkridge MD to perform the above functions will be required)
- Other duties as assigned
- College degree in chemistry, biology or related field of study
- 2+ years of GMP experience
- Salary Range: based on experience
- Comprehensive Benefits: Healthcare, Dental, Vision
Vacancy expired!