Quality Assurance Supervisor - 3rd shift

Nutramax Manufacturing•Lancaster, SC

7d•Onsite

About The Position

The Quality Assurance Supervisor reports to the Quality Assurance (QA) Assistant Manager and is responsible for supervising Quality Assurance Inspectors, Label Issuance, and Team Leads. This role supports all day-to-day operations, techniques, and activities within these departments to fulfill Quality Assurance requirements for products and/or services. The position operates on a 3rd shift, Sunday through Thursday, from 11:15 PM to 7:15 AM.

Requirements

High School Diploma
At least 4 years of experience in an FDA regulated manufacturing environment
Minimum 3 years specifically in Quality Assurance or Quality Control in the nutritional supplement and/or pharmaceutical products manufacturing industry
Minimum 4-5 years of experience in an FDA regulated manufacturing environment
Must be able to effectively communicate with other departments
Must be able to function within a team environment

Nice To Haves

Preferably a degree (either AA or BS/BA)
Prior FDA or equivalent inspection experience is highly recommended

Responsibilities

Supervising Quality Assurance Inspectors, Label Issuance, and Team Leads.
Supporting day-to-day operations, techniques, and activities associated with departments fulfilling Quality Assurance requirements.
Monitoring QAI and Production processes.
Overseeing label cage operations and personnel.
Reviewing and approving protocols.
Collaborating with Production Supervisors to resolve production problems.
Reviewing SOPs.
Reviewing and monitoring environmental conditions records and responding to excursions.
Ensuring compliance with cGMP requirements and regulations through adherence to government regulations, industry standards, and company policies.
Conducting investigations, assessing, and closing deviations, and determining the impact of issues on product quality, safety, and purity.
Reviewing Pest Control and Calibration records.
Working with Production, New Product Development, and other departments to maintain awareness of Quality Systems activities.
Ensuring product quality and conformance to government regulations, industry standards, and company policies.
Developing and deploying processes to assure conformance to government regulations, industry standards, and company policies.
Periodically working varying shift hours to support personnel on those shifts.
Effectively communicating with other departments and functioning within a team environment.
Writing and closing NCRs, reviewing processes, batch records, and procedures, and updating them as needed for improvement or consistency.
Performing other duties as assigned.
Enforcing safe work practices and procedures.
Taking immediate steps to correct unsafe or unhealthful workplace conditions or hazards within their authority and ability.
Taking temporary precautionary measures when hazards cannot be immediately corrected and following up to ensure completion of corrective measures.
Training and periodically reminding employees of what to look for and how to correct or report unsafe conditions or hazards.
Ensuring first aid is provided by an ERT member and that there is no immediate danger to others in case of incidents.
Arranging additional medical treatment for employees if necessary.
Providing emergency transportation if needed.
Notifying additional rescue/response teams if necessary.
Immediately notifying EHS for employees seeking medical treatment for work-related incidents.
Ensuring employees complete their sections of the safety incident report.
Completing the incident report and emailing it to Incident Response before the end of the shift.
Beginning incident investigations.
Securing the scene and keeping it unchanged to accurately collect facts.
Obtaining photos if needed.
Coordinating with EHS to form a cross-functional team to perform 5 WHY - Root Cause investigation, or utilizing other investigation tools for more complicated investigations.
Agreeing upon corrective actions with the cross-functional team based on the root cause.
Emailing the completed investigation to Incident Reporting once the investigation is complete and agreed upon by the cross-functional team.