MQA Specialist I

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.

Additional Duties:

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:

1–3 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.