Quality Supervisor Jobs

About The Position

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.