The QA Supervisor is responsible for leading a team of Quality Assurance Inspectors that provides quality oversight for bulk manufacturing, filling, and packaging operations involved in the production of topical and suppository pharmaceutical products. This role ensures compliance with current Good Manufacturing Practices (cGMP), FDA regulations, internal quality systems, and approved procedures.

The QA Supervisor serves as a key quality resource for Manufacturing, Packaging, Engineering, and Validation. Responsibilities include providing real-time quality support, maintaining quality systems, reviewing and approving quality documentation, supporting investigations, and assisting with audits and inspections to ensure product quality and regulatory compliance.

Schedule: First shift, Monday through Friday. Occasional weekend on-call support may be required.

Salary: $80,000

• Supervise, coach, train, and evaluate QA Inspectors responsible for in-process oversight of manufacturing and packaging operations.
• Ensure manufacturing and packaging activities comply with cGMP requirements, FDA regulations, approved procedures, batch records, and internal quality standards.
• Review production, packaging, and quality documentation for accuracy, completeness, and compliance.
• Provide quality support to operations by addressing quality concerns, conducting risk assessments, and escalating issues when appropriate.
• Author, revise, review, and approve SOPs, Standard Work Instructions (SWIs), forms, and other controlled documents; develop new procedures and improve existing quality systems as needed.
• Lead or support investigations involving deviations, non-conformances, documentation errors, environmental monitoring excursions, and other quality events, ensuring timely implementation of corrective and preventive actions.
• Monitor compliance trends and identify opportunities for continuous improvement.
• Schedule and prioritize team activities and ensure personnel maintain required GMP qualifications and training.
• Support FDA inspections, customer audits, and internal audits while maintaining inspection readiness and assisting with remediation activities.
• Assist with quality metrics, management reviews, and other quality system initiatives.

• Bachelor's degree in a scientific discipline preferred; equivalent experience in a regulated manufacturing environment may be considered in lieu of a degree.
• Minimum of four (4) years of Quality Assurance experience in a regulated industry.
• Previous experience in pharmaceutical, biotechnology, medical device, cosmetics, or another FDA-regulated manufacturing environment is required.
• Demonstrated knowledge of cGMP requirements and quality systems.
• Experience reviewing manufacturing and packaging documentation, investigations, deviations, CAPAs, and change controls.
• Experience authoring and revising SOPs and other controlled documents.
• Previous supervisory or leadership experience preferred.
• Experience supporting FDA inspections and audits preferred.
• Strong written, verbal, organizational, and interpersonal skills.
• Knowledge of SAP and/or electronic quality management systems (eQMS) preferred.