Manager, Quality Assurance
On-siteGreenville, South Carolina, United States
Job Summary
Oversee the day-to-day operations of the Quality Assurance Department, including internal and external audits, document control, compliance, GMP training, and complaint management. Enforce GMP compliance across the organization and strategic partners while developing and maintaining standard operating procedures and quality system policies. Lead the compliance and validation team to implement process, equipment, and cleaning validation programs, and coordinate functional groups for corrective and preventive action responses. Prepare quality reports, conduct monthly meetings with operations to discuss improvements, and monitor the sustainability of identified CAPAs. Collaborate with all departments to ensure the effectiveness of the GMP program and identify continuous improvement activities for Dietary Supplement and IVC product production.
Required Qualifications
- Bachelor's degree in a related field or equivalent job experience
- 2-5 years of experience
- Computer literate and familiar with commercial software such as Microsoft Office: Word, Excel, Access and PowerPoint
- Knowledge of 21 CFR 110 and 111 quality regulations and current Good Manufacturing Practices (cGMP) guidelines
- Capability to work in a manufacturing environment with air-borne powder, noise, and moving equipment
- Able to communicate, write and understand English
- Ability to sit, walk, stand, and reach frequently
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