Quality Assurance Supervisor
On-siteWhitestown, Indiana, United States or Clayton, North Carolina, United States
Job Summary
Manage change requests, reactive maintenance, and deviation/CAPA processes while leading interface with state, federal, ISO, and LSL clients for unannounced and scheduled audits. Direct, mentor, and train direct reports to support career goals and the LSL pipeline, overseeing the vendor qualification program and temperature-controlled warehouse operations with minimal on-call duties. Lead change initiatives by identifying strategic process approaches, determine root causes of discrepancies, and develop corrective actions. Collect QA metrics for the Quality Management Review and oversee sampling and dispensing cleanroom paperwork. Assist with DEA program and holds/releases as directed by clients.
Required Qualifications
- Bachelor of Science (B.S.) degree in Engineering, Science or related field
- Minimum of 3-5 years of experience in Quality in the medical device or pharmaceutical or other regulated industry
- A minimum of two (2) years supervisory experience
- Effective time management skills
- Impeccable verbal and written communication skills
- Ability to conduct appropriate research as needed
- Strong presentation skills
- Strong analytical skills for safety and compliance
- Attention to detail and organization
- Critical thinking
- Interest to work in a fast-paced environment
- Navigate through Quality and Warehouse Management Systems with training – CQ, Tecsys Elite, WebCTRL
- Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
- Strong knowledge of cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
- Verifiable aptitude of FDA regulations
- Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)
- Must be able to travel < 10%
- Must have a valid driver's license
- Must be able to safely conduct occasional lifting of 25 lbs
- Must be able to read at a distance, close to the eyes, and at arm's length with or without correction
Desired Qualifications
- Bachelor of Science (B.S.) degree in Engineering, Science or related field (preferred)
- ASQ and/or ISO Auditor Certifications preferred
- Intermediate public speaking and presentation skills
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