MQA Specialist I
Pine Pharmaceuticals•Tonawanda, NY
•$20 - $23•Onsite
About The Position
The MQA - Finished Product Quality department is responsible for the assurance that all finished compounded products meet cGMP requirements for approval and release.
Requirements
- 1–3 years of experience in pharmaceutical or regulated manufacturing environment
- 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.
Nice To Haves
- 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.
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 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.
- Perform routine quality checks throughout the manufacturing process
- 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.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
