Quality Supervisor

About this position

Quality Supervisor

Reese Consumer Health is a privately held manufacturer of OTC branded and private‑label products selling to national and regional chains, food and grocery stores, drug wholesalers, co‑ops and independent pharmacies. Since our small beginnings in 1907, Reese Consumer Health has continued to grow and thrive as a 4th‑generation, family‑run business. We supply the pharmaceutical industry and the public with high‑quality, unique medications that are stronger and more effective than either name brands or generic equivalents, including equivalents to the name brands.

We have expanded our production capabilities by adding more equipment to our facilities to keep up with the growing range of OTC and healthcare products. Incorporating our company values—Accountability, Continuous Improvement, Customer Focus, Integrity, and Quality—this role is a member of quality management responsible for maintaining and improving the company’s Quality Management Systems.

The Quality Assurance Supervisor leads quality control efforts and infrastructure in both Quality and Production, ensuring compliance with cGMP and company standards.

• Train, motivate, and evaluate the quality team to meet the company’s quality objectives.
• Support the hiring and onboarding process in collaboration with the department director.
• Collaborate with HR to build a quality training program for continuous improvement and new hires.
• Audit and review the manufacturing process for compliance to policies and procedures and assist in investigating non‑conformities.
• Participate in data collection, development, and issuance of management review documents.
• Perform root cause analysis and other risk assessment activities to identify effective corrective and preventative actions.
• Plan work, make assignments, and coordinate workflow to balance safety, quality, and moral standards to meet company objectives and customer expectations.
• Perform root cause analysis and CAPA follow‑up (if required) for complaints and inquiries received from the field.
• Evaluate training needs for quality personnel, perform on‑the‑job training / re‑training, and evaluate training effectiveness.
• Review and approve change controls applicable to manufacturing processes and procedures, analytical procedures, and related batch records/testing SOPs; assure appropriate reports are issued, approved, and implemented.
• Manage cGMP new employee and annual training for all employees at each facility.
• Oversee cGMP aspects of production records and develop quality and production SOPs using the change control process, as identified through observation or the internal audit process.
• Communicate quality issues, trends, and losses to operations management and identify appropriate resolutions with assistance.
• Perform Annual Product Reviews (APR).
• Maintain a rotating schedule for NBE or own merit testing with a minimum of one product per month on new items and legacy products.
• Maintain oversight of the maintenance/calibration program.
• Perform periodic review of SOPs and internal audits according to applicable procedures.
• Assist with internal and external quality audits including development of responses to observations.
• Apply systematic critical thinking to solve company issues.
• Other tasks as needed to support department and company goals and initiatives.

• Bachelor’s degree in science, mathematics, engineering or related field.
• Five or more years of experience in Quality Assurance / Quality Control, with a minimum of five years cGMP experience in a pharmaceutical manufacturing environment.
• Familiarity with 21 CFR parts 210/211, part 111, and part 820 desired.
• Ability to lead and direct others.
• Microsoft Office suite experience.
• Experience with regulatory authorities (FDA, FTC, EPA) and inspection preparation, execution, and response preferred.
• Knowledge of inspection and control methods, techniques, and documentation.
• Excellent written and verbal communication skills.
• Strong computer skills, including ability to manage quality control applications.
• Ability to travel as needed.
• Six Sigma / Lean manufacturing training desired.