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 monitoringAssuring that all GMP requirements and regulations are met through compliance to government regulations, industry standards and Company policiesProtocol review and approvalReviewing environmental conditions records and responding to excursionsWork with Production Supervisors to resolve production problemsDocument ControlReview and approval of SOPsAssuring that all applicable cGMP requirements and regulations are met through compliance to government regulations, industry standards and company policiesBatch record documentation review and approvalProduct / 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.
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