Quality Assurance Supervisor - 2nd shift

Nutramax Manufacturing•Lancaster, SC

22h

About The Position

The Quality Assurance Supervisor reports to the Quality Assurance Assistant Manager and supervises Quality Assurance Inspectors, Label Issuance personnel, and Team Leads. The position supports day-to-day operations, techniques, and activities in those departments to fulfill product and service quality requirements. The supervisor oversees Quality Assurance staff and ensures compliance with applicable current Good Manufacturing Practice (cGMP) requirements, government regulations, industry standards, and company policies. The role also carries workplace safety responsibilities, including enforcing safe work practices, addressing hazards, reporting and investigating incidents, and coordinating root-cause investigations and corrective actions with EHS and cross-functional teams. The role may involve exposure to raw materials or finished goods derived from a range of potential allergens, including bovine, milk, soy, shellfish, pork, chicken, tuna, eggs, peanuts, tree nuts, fish, wheat, and sesame.

Requirements

At least 4 years of experience in an FDA-regulated manufacturing environment; the posting also states a 4–5 year minimum.
At least 3 years specifically in Quality Assurance or Quality Control, including experience in the nutritional supplement and/or pharmaceutical products manufacturing industry.
High school diploma.
Ability to communicate effectively with other departments and function within a team environment.
Ability to work varying shift hours periodically to support personnel on other shifts.

Nice To Haves

Associate or bachelor's degree preferred.
Prior FDA or equivalent inspection experience is highly recommended.

Responsibilities

Supervise Quality Assurance Inspectors and Production process monitoring.
Oversee label cage operations and personnel.
Review and approve protocols.
Work with Production Supervisors to resolve production problems.
Review SOPs, processes, batch records, and procedures; update documentation as needed for improvement or consistency.
Review and monitor environmental condition records and respond to excursions.
Ensure applicable cGMP requirements, government regulations, industry standards, and company policies are met.
Conduct investigations; assess and close deviations; determine potential impacts on product quality, safety, and purity.
Review pest control and calibration records, among other records.
Coordinate with Production, New Product Development, and other departments to maintain awareness of Quality Systems activities.
Develop and deploy processes to ensure conformance to regulations, standards, and company policies.
Write and close NCRs.
Work varying shift hours periodically to support personnel on those shifts.
Communicate effectively with other departments and function within a team environment.
Perform other duties as assigned.
Enforce safe work practices and procedures, encourage employees to identify hazards, and take steps to correct unsafe conditions or implement temporary precautions when needed.
Train and periodically remind employees how to identify, correct, or report unsafe conditions and hazards; follow up to ensure corrective measures are completed.
Respond to workplace incidents by ensuring first aid and immediate safety, arranging medical treatment or transportation as needed, and notifying response teams when necessary.
Immediately notify EHS when employees seek medical treatment for work-related incidents; ensure employees complete their portions of safety incident reports.
Complete incident reports and email them to Incident Response before the end of the shift; begin investigations, secure the scene, and obtain photographs if needed.
Coordinate with EHS to form a cross-functional team for a 5 WHY root-cause investigation or other investigation methods, agree on corrective actions, and email the completed investigation to Incident Reporting.