Quality Assurance Assistant Manager

Summary of the Position: The Assistant Quality Assurance Manager reports to senior Quality Assurance Manager. This person supervises Quality Assurance Generalists, and Label Issuance. The QA Assistant Manager 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 Assistant Manager is responsible for Supervising those individuals within the QA department that includes but is not limited to the following:

• • QAG 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.

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