Quality Assurance Supervisor
About The Position
The Quality Assurance Supervisor — Investigations, CAPA, and Change Control executes and oversees site Quality System activities related to deviation investigations, Corrective and Preventive Actions (CAPA), and change control. The role ensures compliance with FDA regulations, ICH guidance, and company quality standards. It drives timely, thorough investigations, applies root cause analysis, implements sustainable CAPAs, and manages change control records throughout their lifecycle. The supervisor partners with Manufacturing, Quality Control, Validation, and Supply Chain to uphold product quality, ensure data integrity, and maintain regulatory readiness. The role reports to the QA Manager and is located at the Johnson City plant.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related technical field.
- At least 5 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment.
- Demonstrated expertise managing deviations, CAPAs, and change control systems.
- In-depth knowledge of 21 CFR Parts 210, 211, and 11; ICH Q7–Q10; and relevant USP chapters.
- Proficiency in root cause analysis tools and Six Sigma methodologies.
- Experience using electronic Quality Management Systems such as MasterControl, Veeva, or ETQ Reliance.
- Familiarity with data integrity requirements and ALCOA+ compliance.
- Ability to track and deliver on commitments with minimal supervision.
Nice To Haves
- Experience with FDA inspections and supporting regulatory audits is strongly preferred.
Responsibilities
- Manage and execute product and system investigations, including deviations, OOS/OOT results, nonconformances, and complaint-related issues.
- Ensure timely investigation initiation, impact assessment, and documentation in accordance with site SOPs and applicable regulations.
- Apply root cause analysis methods, including 5 Whys, Ishikawa, and Six Sigma tools such as DMAIC, FMEA, and process mapping.
- Facilitate cross-functional investigation meetings and maintain inspection-ready documentation.
- Drive the creation, approval, and execution of CAPAs.
- Ensure CAPAs are specific, measurable, timely, and effective in addressing root causes.
- Monitor CAPA progress, escalate overdue items, and support effectiveness checks.
- Trend and report CAPA data for site quality metrics and management review.
- Manage and QA-approve changes affecting procedures, materials, equipment, facilities, test methods, and validated systems.
- Evaluate proposed changes for regulatory impact, validation requirements, and risk mitigation using ICH Q9 principles.
- Coordinate stakeholder tasks and ensure they are completed and documented before change control closure.
- Track and trend change control metrics and maintain audit readiness.
- Ensure records are complete, contemporaneous, and compliant with ALCOA+ principles.
- Support FDA, customer, and internal audits by presenting investigation files, CAPA evidence, and change control history.
- Contribute to Quality Risk Management and participate in FMEAs and risk evaluations as required.
- Identify and implement improvements to investigation and CAPA lifecycle efficiency and compliance.
- Contribute to site-wide quality initiatives, including audit readiness, inspection-trend gap closure, and right-first-time performance.
- Train and mentor QA personnel on investigation techniques, documentation standards, and data integrity.
Benefits
- Competitive compensation, including base salary and annual performance bonus.
- Flexible PTO and holidays.
- Parental leave.
- Healthcare benefits.
- HSA match.
- 401(k) match.
- Employer-paid life and disability insurance.
- Pet insurance.
- Wellness discounts.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
