Job Description

The hours for this position are Sunday - Thursday 11:15pm - 7:15am.

Summary of the Position: The Quality Assurance Supervisor reports to The Senior Quality Assurance Manager. This person supervises Quality Assurance Generalists, and Label Issuance. The QA Supervisor supports all of 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.

Roles and Responsibilities:

The QA Supervisor is responsible for supervising those individuals within the QA department that include but are not limited to the following:

• QAG and Production process monitoring
• Responsible for Label Cage operations and personnel
• Protocol review
• Work with Production Supervisors to resolve production problems
• Review of SOPs
• Reviewing 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 PMs, Pest Control, Calibration records, etc
• Working with Production, New Product Development, and other necessary departments to maintain awareness of Quality Systems activities.
• Product quality and conformance to government regulations, industry standards, and Company policies.
• Understanding and deploying processes to assure conformance to government regulations, industry standards and Company policies.
• Must periodically be able to work varying shift hours in support of personnel on those shifts.
• Must be able to effectively communicate with other departments and function within a team environment.
• Performance of other duties as assigned.

Minimum Requirements: The QA Supervisor must have at least 3-5 years of experience in an FDA regulated manufacturing environment, with 3 years specifically in Quality Assurance or Quality Control. Prior FDA or equivalent inspection experience is highly recommended.

Education and Experience : BS Degree or BA Degree with a Science major or concentration and continuing education credits or certifications in the pharmaceutical industry through a reputable professional society. Minimum of 5 years’ experience in Quality Assurance in the nutritional supplement and/or pharmaceutical products manufacturing industry.

Supervisory Responsibilities:

• Quality Assurance staff
• Enforce Safe Work Practices: It's the supervisor’s responsibility to enforce safe work practices and procedures; failure to do so is an invitation for accidents to occur. Workers must be encouraged to identify unsafe or unhealthful workplace conditions or hazards.
• Correct Unsafe Conditions: Supervisors' must take immediate steps to correct unsafe or unhealthful workplace conditions or hazards within their authority and ability to do so. When an unsafe or unhealthful workplace condition or hazard cannot be immediately corrected, the supervisor must take temporary precautionary measures. Supervisors must follow-up to ensure that corrective measures are completed in a timely manner to address the hazard.
• Prevent Lingering Unsafe or Unhealthful Workplace Conditions or Hazards: It's the supervisor's responsibility to train and periodically remind employees of what to look for and how to correct or report unsafe conditions or hazards. If a hazard is identified, the supervisor must act to correct.
• Incidents Reporting: Immediately ensure 1st aid is provided by a ERT member and ensure there is no immediate danger to others. Arrange additional medical treatment for the employee if necessary. Provide emergency transportation, if needed. Notify additional rescue/response teams if necessary.
• Immediately notify EHS for employees seeking medical treatment for work related incidents. Ensure employee completes their sections of the safety incident report.
• Complete the incident report and email to Incident Response before the end of your shift. Begin incident investigation Secure the scene. Keep it unchanged to accurately collect the facts. Obtain photos if needed.
• Coordinate 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. Corrective action(s) will be agreed upon by the cross functional team based on the root cause. Once the investigation is complete and agreed upon by the cross functional team, email the completed investigation to Incident Reporting

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