MQA Specialist II

Job Description

Job Description

Position Summary:

The MQA - Finished Product Quality department is responsible for the assurance that all finished compounded products meet cGMP requirements for approval and release.

Essential Functions:

Visual Inspection Oversight: Verify visual inspection results for all production batches, including but not limited to the following:

• Perform Acceptable Quality Limit (AQL) sampling for all finished product batches.
• Calculate defect rates and yield percentages following completion of inspection
• Update applicable 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.

In-Process Quality Checks: Perform routine quality checks throughout the manufacturing process, including but not limited to the following:

• Internal walkthroughs and spot checks to evaluate audit readiness.
• Verification of remaining product volume at batch completion.
• Label issuance, reconciliation, and approval.
• Conduct label AQL sampling.
• Perform visual inspection audits.
• Provide operator coaching and on-the-floor training as needed.

Performance of Batch Review: Responsible for ensuring thorough and accurate review of all batch-related documentation and materials following applicable batch record checklist including but not limited to the following:

• Review for completeness
• Confirm batch information and conformance on all attached label images
• Conformity of defect percentages and batch yield
• Review of batch materials list and Master production list
  • Verification of all expiration dates and items
• Review of bulk powder and QS weights

• Update applicable trending data

Additional Duties:

• Responsible for the physical movement of retention samples
• Reserve sample inspection
• Participate annually in “train the trainer” program
• Support any other tasks as assigned by the supervisor or required by updated Standard Operating Procedures (SOPs) and company policies.
• Ensure all activities remain compliant with current Good Manufacturing Practices (cGMP) and applicable regulatory standards.

Education and Experience:

• 2–4 years of experience in pharmaceutical or regulated manufacturing environment
  • Strong preference given to candidates with understanding of FDA, cGMP, CFR Parts 210 and 211
• Prior experience in visual inspection, batch record review, or in-process quality checks is highly preferred.

Knowledge, Skills and Abilities:

• 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) and experience with MasterControl or similar quality management systems.
• Exceptional attention to detail and keen observational skills, particularly during inspection activities.
• Ability to work independently in a dynamic, fast-paced manufacturing environment.
• Strong verbal and written communication skills, with the ability to clearly document findings and escalate issues when necessary.
• Dependable attendance and effective time management.
• Collaborative, team-oriented mindset with a willingness to assist in cross-functional tasks and provide training support when needed.