Quality Assurance Supervisor - 3rd shift

Nutramax Laboratories•Lancaster, SC

6d•Onsite

About The Position

The Quality Assurance Supervisor reports to the Quality Assurance (QA) Assistant Manager. This person supervises Quality Assurance Inspectors, Label Issuance, and Team Leads. The QA Supervisor supports all the day-to-day operations, techniques, and activities associated with those departments that are used to fulfill the Quality Assurance requirements of the product and/or service.

Requirements

High School Diploma
At least 4 years of experience in an FDA regulated manufacturing environment
3 years specifically in Quality Assurance or Quality Control
At least 4-5 years of experience in an FDA regulated manufacturing environment
A minimum 3 years specifically in Quality Assurance or Quality Control in the nutritional supplement and/or pharmaceutical products manufacturing industry.

Nice To Haves

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

Responsibilities

Supervising individuals within the QA department including QAI and Production process monitoring.
Responsible for label cage operations and personnel.
Protocol review and approval.
Work with Production Supervisors to resolve production problems.
Review of SOPs.
Reviewing and monitoring environmental conditions records and responding to excursions.
Assuring that all applicable cGMP requirements and regulations are met through compliance to government regulations, industry standards and company policies.
Conducting investigations, assessing, and closing deviations, determining impact of the issues that could affect product quality, safety and purity.
Reviewing of Pest Control, Calibration records, etc.
Working with Production, New Product Development, and other necessary 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 in support of personnel on those shifts.
Effectively communicating with other departments and functioning within a team environment.
Writing and closing NCRs, review of processes, batch records and procedures and updating as needed for improvement or consistency.
Performance of other duties as assigned.
Supervising Quality Assurance staff.
Enforcing safe work practices and procedures.
Correcting unsafe or unhealthful workplace conditions or hazards.
Taking temporary precautionary measures when hazards cannot be immediately corrected.
Following up to ensure corrective measures are completed in a timely manner.
Training and reminding employees of what to look for and how to correct or report unsafe conditions or hazards.
Acting to correct identified hazards.
Ensuring 1st aid is provided by an ERT member and ensuring there is no immediate danger to others.
Arranging additional medical treatment for employees if necessary.
Providing emergency transportation if needed.
Notifying additional rescue/response teams if necessary.
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 to Incident Response before the end of the shift.
Beginning incident investigation by 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 – Other investigation tools may be utilized for more complicated investigations.
Agreeing upon corrective action(s) by 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.