Quality Assurance Associate
A Mid-Size Pharma company is seeking an experienced Quality Assurance (QA) professional to join the team of one of our esteemed clients based in Kentucky, USA. As a QA Associate with this leading pharmaceutical company, you will play an essential role within their organization by assisting with CAPA and Change Control Systems development while ensuring compliance-related activities align with GXP regulations.
The QA Associate will have the following responsibilities...
- Developing and maintaining QMS and both internal and external audits.
- Reviewing and approving cGMP documentation including validation protocols, development reports and other related documents.
- Assisting managers with daily projects & activities
- Work on CFR Part 11 requirements along regulatory guidelines related to Pharmaceuticals Industries.
- Coordinate and participate in regulatory inspections and customer audits.
- Work cross functionally with Quality Control teams, Validation teams, and Manufacturing and Production teams.
- Review and assist in complaint investigations.
The QA Associate should meet the following qualifications...
- Bachelor's degree or higher qualification relevant to Quality Specialist/Quality assurance roles.
- 2 years of cGMP experience
- Experience in quality systems auditing
Benefits:
- Health, Dental, Vision
- 401k
- Relocation Assistance
