Pine Pharmaceuticals · 12 hours ago
MQA Specialist I
Tonawanda, New York, United States
Full-time
Onsite
Entry Level
$20/hr - $23/hr
1+ years expPine Pharmaceuticals is focused on ensuring that all finished compounded products meet cGMP requirements for approval and release. The MQA Specialist I will be responsible for visual inspection oversight, in-process quality checks, and ensuring compliance with regulatory standards.
Health CareManufacturingPharmaceuticalRetail
Responsibilities
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
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
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
Qualification
Required
Entry-level 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
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
Preferred
Understanding of FDA, cGMP, CFR Parts 210 and 211
Prior experience in visual inspection, batch record review, or in-process quality checks
Company
Pine Pharmaceuticals
Pine Pharmaceuticals manufactures and supplies anesthetics, antibiotics, intranasal solutions, steroids, topical ophthalmic & IV solutions.
201-500 employees
Funding
Current Stage
Growth StageRecent News
Business Journals
2023-07-28
Business Journals
2023-05-23
2023-05-11
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