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About the Role

The MQA - Finished Product Quality department ensures all finished compounded products meet cGMP requirements for approval and release.

Responsibilities

• Verify visual inspection results for all production batches.
• Perform Acceptable Quality Limit (AQL) sampling for all finished product batches.
• Calculate defect rates and yield percentages.
• Update trending data based on visual inspection findings.
• Conduct in-process reviews of operator findings during visual inspection, escalating issues as necessary.
• Escalate all visual inspection failures and deviations per established procedures.
• Perform routine quality checks throughout the manufacturing process.
• Conduct internal walkthroughs and spot checks to evaluate audit readiness.
• Verify remaining product volume at batch completion.
• Manage label issuance, reconciliation, and approval.
• Conduct label AQL sampling.
• Perform visual inspection audits.
• Provide operator coaching and on-the-floor training.
• Ensure thorough and accurate review of all batch-related documentation and materials.
• Review batch records for completeness.
• Confirm batch information and conformance on all attached label images.
• Verify conformity of defect percentages and batch yield.
• Review batch materials list and Master production list.
• Verify all expiration dates and items.
• Review bulk powder and QS weights.
• Responsible for the physical movement of retention samples.
• Perform reserve sample inspection.
• Participate annually in “train the trainer” program.
• Support other tasks as assigned by the supervisor or required by updated SOPs and company policies.
• Ensure all activities remain compliant with current Good Manufacturing Practices (cGMP) and applicable regulatory standards.

Requirements

• 2–4 years of experience in pharmaceutical or regulated manufacturing environment.
• Prior experience in visual inspection, batch record review, or in-process quality checks is highly preferred.

Skills

• Solid understanding of visual defect classification and AQL sampling plans.
• Strong adherence to Standard Operating Procedures (SOPs) and company policies.
• Basic math proficiency, including the ability to calculate percentages, counts, yields, and ensure documentation accuracy.
• Demonstrated proficiency in Good Documentation Practices (GDP).
• Skilled in Microsoft Office applications (Excel, Word, Outlook).
• Experience with MasterControl or similar quality management systems.
• Exceptional attention to detail and keen observational skills.
• Ability to work independently in a dynamic, fast-paced manufacturing environment.
• Strong verbal and written communication skills.
• Dependable attendance and effective time management.
• Collaborative, team-oriented mindset.
• Willingness to assist in cross-functional tasks and provide training support.

Experience Level

• 2-4 years