Role OverviewThe Quality Specialist II - Audit Team is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analysis where needed, and performing quality and compliance training as needed.
What You Will Do
Performs quality review of complex documents, all types of data, protocols, and/or reports. Supports quality floor audits and/or floor inspections. Supports client and regulatory agency audits and inspections, as needed.
Why It Might Be a Fit
The Quality Specialist II - Audit Team will provide guidance and mentoring for other compliance employees. Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
Requirements
- B.S./B.A./M.S. in a related field with 2–7+ years relevant experience or equivalent.
- A.A.S. in a related field with 10+ years relevant experience or equivalent.
- Relevant GMP experience preferred.
Benefits
- 100% on-site position
- Occasional travel to other sites to support Audits
- 1st Shift: Monday - Friday, 8:00am - 5:00pm
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