Quality Supervisor

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

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

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.

Benefits

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