MQA Specialist II

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.