Job Summary

The Quality Assurance Supervisor is responsible for executing and overseeing key elements of the site's Quality Systems related to deviation investigations, Corrective and Preventive Actions (CAPAs), and change controls. This role ensures compliance with FDA (21 CFR Parts 210, 211, 1 1), ICH QIO, and company-specific quality standards. The QA Supervisor will drive timely, thorough, and effective investigations, apply root cause analysis techniques, implement sustainable CAPAs, and manage the lifecycle of change control records.

As a cross-functional supervisor, the QA Supervisor partners closely with Manufacturing, Quality Control, Validation, and Supply Chain to uphold product quality, ensure data integrity, and maintain a state of regulatory readiness

Reporting to: Sr. Manager, Quality Assurance

Location: Johnson City, TN – onsite 5 days/week

Responsibilities/Essential Duties:

Investigations & Root Cause Analysis (NCMs):
Manage and execute product and system investigations including deviations, OOS/OOT results, nonconformances, and complaint-related issues.
Ensure timely initiation, impact assessment, and documentation of investigations in accordance with site SOPs and 21 CFR \211.192.
Apply structured root cause analysis methodologies such as 5 -Whys, Ishikawa (fishbone), and Six Sigma tools (e.g., DMAIC, FMEA, process mapping).
Facilitate cross-functional investigation meetings and maintain high-quality documentation aligned with inspection standards.
Compliance & Data Integrity:
Ensure all 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 processes and participate in FMEAs and risk evaluations as required.
CAPA Management:
Drive the creation, approval, and execution of Corrective and Preventive Actions (CAPAs).
Ensure all CAPAs are specific, measurable, timely, and effective in addressing the root cause.
Monitor CAPA progress, escalate overdue items, and support effectiveness checks to verify sustainable resolution.
Trend and report CAPA data to support site Quality Metrics and Management Review.
Continuous Improvement:
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.
Provide training and mentorship to QA personnel on investigation techniques, documentation standards, and data integrity.
Change Control Oversight:
Manage and QA-approve changes impacting procedures, materials, equipment, facilities, test methods, and validated systems.
Evaluate proposed changes for regulatory impact, validation requirements, and risk mitigation using ICH Q9 principles.
Collaborate with stakeholders to ensure all associated tasks are defined, executed, and documented prior to closure.
Track and trend change control metrics and ensure readiness for audits.

Basic Qualifications:

Bachelor’s degree & 5+ years’ directly related experience.

Preferred Qualifications:

Bachelor's degree in Life Sciences, Engineering, or related technical field.
Minimum 5 years’ Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment.
Demonstrated expertise in managing deviations, CAPAs, and change control systems.
Experience with FDA inspections and supporting regulatory audits is strongly preferred.
In-depth knowledge of21 CFR Parts210, 211, 11, ICH Q7-QIO, and relevant USP chapters.
Proficiency in root cause analysis tools and Six Sigma methodologies.
Experience using electronic Quality Management Systems (eQMS) such as Master Control, Veeva, or ETQ Reliance.
Familiarity with data integrity requirements and ALCOA+ compliance.
Investigative Rigor: Executes high-quality, inspection-ready investigations with accurate root cause identification.
CAPA Execution: Ensures timely, effective, and risk-based corrective actions.