Quality Assurance Supervisor - 2nd shift

Nutramax Laboratories•Lancaster, SC

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 role supports day-to-day operations, techniques, and activities across those departments to fulfill product and service quality requirements. The position is full-time and scheduled Monday through Friday, 3:15 p.m. to 11:30 p.m.; periodic work at varying shift hours may be required to support personnel on other shifts. The supervisor oversees quality assurance activities and personnel, including production process monitoring and label cage operations. Responsibilities include reviewing and approving protocols, reviewing SOPs and batch records, monitoring environmental records and responding to excursions, and ensuring compliance with applicable cGMP requirements, government regulations, industry standards, and company policies. The supervisor also investigates, assesses, and closes deviations and NCRs; evaluates potential effects on product quality, safety, and purity; reviews records such as pest control and calibration records; and works with Production, New Product Development, and other departments on Quality Systems activities and production issues. The role includes enforcing safe work practices, correcting or mitigating workplace hazards, and handling incident response and investigation in coordination with EHS and other teams. The position may involve exposure to raw materials or finished goods derived from allergen sources, 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 describes this as 4–5 years.
At least 3 years of Quality Assurance or Quality Control experience, specifically in nutritional supplement and/or pharmaceutical product manufacturing.
High school diploma.
Ability to communicate effectively with other departments and function within a team environment.
Ability to periodically work varying shift hours in support of personnel on those shifts.
Prior FDA or equivalent inspection experience is highly recommended.

Nice To Haves

Associate degree or bachelor's degree.
Prior FDA or equivalent inspection experience.

Responsibilities

Supervise Quality Assurance Inspectors, Label Issuance personnel, and Team Leads.
Support day-to-day operations and activities associated with Quality Assurance requirements.
Monitor production processes and 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 them 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 followed.
Conduct investigations, assess and close deviations, and determine potential impacts on product quality, safety, and purity.
Review pest control, calibration, and other applicable 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.
Communicate effectively with other departments and work within a team environment.
Periodically work varying shift hours to support personnel on those shifts.
Perform other duties as assigned.
Enforce safe work practices and procedures; train and remind employees to identify, correct, or report workplace hazards.
Take immediate steps to correct hazards within the supervisor’s authority, establish temporary precautions when needed, and follow up on corrective actions.
Respond to workplace incidents by arranging first aid and medical care as needed, ensuring notifications and incident reports are completed, securing the scene, and beginning an investigation.
Coordinate with EHS and a cross-functional team to investigate incidents, determine root causes, and agree on corrective actions.