Summary of the Position: The Quality Assurance Assistant Manager reports to the Quality Assurance Director/ Senior Quality Assurance Manager. The QA Assistant Manager supports all manufacturing and packaging operation activities and techniques that present an impact patient safety and/ or product quality.

Roles and Responsibilities:

The QA Assistant Manager is responsible for Supervising those individuals within the QA department that includes but is not limited to the following:

• • QA Inspector and Production process monitoring
  • Responsible for Label Cage operations and personnel
  • Protocol review and approval
  • Work with Production Supervisors to resolve production problems
  • Review and approval 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 first, second and third 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.
• Regular attendance is required.

Minimum Requirements: The Assistant QA Manager must have at least 5-7 years of experience in an FDA regulated manufacturing environment, with 5 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 10 years' experience in Quality Assurance in the nutritional supplement and/or pharmaceutical products manufacturing industry

Supervisory Responsibilities: Quality Assurance staff