The Quality Assurance Supervisor supports the Badger Mission and Principles as a member of the Quality Unit. This role is responsible for leading the QA operational team, ensuring consistent execution of quality systems, accurate and timely QA outputs, and compliance with FDA, cGMP, and certification requirements.

The QA Supervisor provides day-to-day leadership, prioritization, and oversight for QA coordinators and specialists responsible for document control, training administration, batch record issuance and review, deviations management, and material sampling and receiving. The QA Supervisor ensures QA systems are executed consistently, risks are identified and escalated appropriately, and the QA team is trained, supported, and inspection ready.

This role reports to the Director of Quality and operates with delegated authority for routine QA decisions, escalating higher-risk issues, systemic concerns, or resourcing needs as required.

Essential Responsibilities:

Team Supervision

· Directly supervise the Document Control Coordinator, Batch Record Review Coordinator, QA Coordinator, Deviations Coordinator, and QA Sampling & Receiving Coordinator.

· Ensure daily coverage and workload prioritization for all QA operational functions.

· Provide onboarding, training oversight, coaching, performance feedback, and corrective guidance for QA staff.

· Conduct regular check-ins, ABC meetings, and performance discussions with team members.

· Address employee performance, conduct, and interpersonal concerns in partnership with the Director of Quality and HR.

· Approve timecards and manage weekly payroll for the QA team.

· Ensure the accuracy, consistency, and regulatory compliance of work products generated by QA coordinators and specialists, providing review, feedback, and approval as required.

Quality Systems Oversight

· Ensure QA procedures, work instructions, forms, and records are accurate, current, and effectively implemented.

· Review and approve controlled documents and changes within delegated authority.

· Oversee execution of QA training programs and ensure training records remain current and compliant.

· Monitor system performance and identify gaps, trends, or improvement opportunities across QA operations.

Batch Documentation & Release Oversight

· Provide oversight and guidance for batch record issuance, execution review, and documentation correction activities.

· Support resolution of documentation discrepancies, missing information, or deviations identified during batch review.

· Ensure batch documentation processes support timely and compliant product release.

Deviations, CAPA & Complaints Oversight

· Oversee execution of deviation, nonconformance, CAPA, and complaint workflows.

· Review investigation quality, risk assessments, and CAPA plans for completeness and objectivity.

· Determine escalation thresholds and review higher-risk deviations, investigations, and CAPAs prior to Director of Quality review.

· Review QA metrics and trend data and contribute to Annual Product Review inputs.

Ingredient, Component and Art Receiving

· Ensure QA oversight of ingredients, components, and artwork receiving, sampling, and release activities.

· Oversee accuracy, completeness, and compliance of receiving documentation, specifications, and related records.

· Coordinate with QA Sampling & Receiving and Supplier Qualification resources as needed.

Internal Audit & Inspection Readiness

· Lead and oversee the QA internal audit program, including planning, execution by qualified auditors, reporting, and follow-up.

· Support FDA inspections and external audits as QA subject matter lead.

· Ensure QA team readiness for inspections through training, record accuracy, and mock audits.

Continuous Improvement

· Identify and lead continuous improvement initiatives within QA operations.

· Collaborate with the Director of Quality on system enhancements, resourcing needs, and cross-functional improvements

Other Tasks

· Back up the Director of Quality, as needed

· Serve as member of the audit team during FDA inspections

· Back up QA team as necessary

· Other duties as required

Pay starting at $65,000/annual salary; commensurate with experience

Education & Experience:

· Bachelor’s degree in a scientific, technical, or quality-related field preferred; equivalent experience considered.

· Minimum of 3 years of experience in Quality Assurance, Quality Systems, or Regulatory roles within a regulated environment (OTC drug, cosmetic, dietary supplement, or similar).

· Prior experience leading or supervising QA staff, projects, or functional workstreams required.

· Strong working knowledge of cGMP, FDA regulations, and quality system requirements.

· Experience overseeing document control, training systems, batch documentation, deviations, CAPA, and audit activities.

· Experience supporting or leading internal and external audits.

Skills:

· Strong leadership, coaching, and accountability skills.

· Excellent judgment and ability to prioritize and escalate quality risks.

· Strong written and verbal communication skills across all organizational levels.

· High attention to detail with the ability to balance execution and oversight.

· Ability to manage multiple QA functions simultaneously in a fast-paced environment.

· Proficiency with QMS platforms, ERP systems (e.g., Syspro), and Microsoft Office.

Physical Requirements

Physical requirements for the job include but are not limited to prolonged periods sitting at a desk and working on a computer. Must be able to lift to 15 pounds at times. Employees should be able to perform the essential functions of the job with or without reasonable accommodation.

Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k, IRA)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)
Family Leave (Maternity, Paternity)
Short Term & Long Term Disability
Wellness Resources

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Quality Supervisor