Job Description

Roles and Responsibilities:

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

• • QAG and Production process monitoring
  • Assuring that all GMP requirements and regulations are met through compliance to government regulations, industry standards and Company policies
  • Protocol review and approval
  • Reviewing environmental conditions records and responding to excursions
  • Work with Production Supervisors to resolve production problems
  • Document Control
  • Review and approval of SOPs
  • Assuring that all applicable cGMP requirements and regulations are met through compliance to government regulations, industry standards and company policies
  • Batch record documentation review and approval
  • Product/Raw material/Component release (following testing)
• Working with Production, Regulatory Affairs, Marketing, 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.
• Developing and deploying the Quality systems to ensure products conform to defined requirements.
• Understanding and deploying processes to assure conformance 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 customer complaints/AERs to ensure customer satisfaction and potential CAPAs are completed for nonconformance.
  • Reviewing of PMs, Pest Control, Calibration records, etc.
• Must be able to effectively communicate with other departments and function within a team environment.
• Must periodically work second and third shift hours in support of personnel on those shifts.
• Performance of other duties as assigned.

Minimum Requirements: The QA Supervisor 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 in the pharmaceutical industry through a reputable professional society. An Associate degree with 10 plus years in pharmaceutical manufacturing experience will be considered.