Job Details

ID #10557112
State Maryland
City Baltimore
Job type Permanent
Salary USD TBD TBD
Source Zachary Piper Solutions, LLC
Showed 2021-03-03
Date 2021-03-02
Deadline 2021-05-01
Category Software/QA/DBA/etc
Create resume

QA Associate

Maryland, Baltimore, 21201 Baltimore USA

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
Qualifications for the QA Associate include:
  • College degree in chemistry, biology or related field of study
  • 2+ years of GMP experience
Compensation for the QA Associate includes:
  • Salary Range: based on experience
  • Comprehensive Benefits: Healthcare, Dental, Vision

Vacancy expired!

Subscribe Report job