Job Title: Manufacturing Quality Assurance Specialist (MQA Specialist)
Pay: $17.00 - $19.00/hour
Job Overview: Responsible for the quality oversight and assistance to Production processes, supporting departments, and labs. review of all finished product documentation and ensure compliance with cGMP, SOP's, and FDA regulations, for release of product. Provide recommendations and resolutions to take appropriate action to ensure compliance.
Review of product batch records and disposition of batch records to meet release schedules through auditing function.
Analyze and recommend corrective action needed for successful compliance of batch records.
Assist in the review and revision of SOP’s, protocols, and special studies required for compliance with batch record.
Assures compliance to SOP's and cGMP's.
Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.
Performs analysis of fill operations utilizing SPC software.
Responsible to monitor the Production floor to ensure all operations are being performed according to written procedures.
Ensures line clearances and appropriate QA procedures are performed and followed within the Packaging areas.
Review and verification of Microbiology, Chemistry, Compounding, Labeling & Functionality from Packaging in the LIMS system.
Involved in data entry for the weekly meetings and present information relating to status of all batches.
Review of Material Management forms to assure accuracy of information and components for production.
Supports management in investigations, identification and recommend resolution of issues/non-compliance.
Key Skills: Manufacturing, Quality Control, GMP, Pharmaceutical, SPC, Batches, SOP's, Visual Inspection, Chemicals, FDA, Protocols, CAPA
BS in science discipline preferred, or High School diploma with 3+ years of experience or knowledge in a GMP-regulated industry.
Qualifies as a Visual Inspector to perform AQL inspections.
Proven communication (oral and written) and proofreading skills.
Prior troubleshooting, auditing of production documentation and QC experience a plus.
SPC software knowledge a plus.
Pharmaceutical experience a plus.
Pinpoint Pharma, LLC specializes in placing scientifically experienced individuals in positions within the pharmaceutical, medical device, chemical, and food industries. This includes both temporary and direct hire staffing, as we tailor our search to your business needs.
At Pinpoint Pharma, we treat every business opportunity as a customized solution designed to fit our client's and consultant's individual specifications. Our methods of acquiring top talent rely on our industry contacts and developed talent pool of qualified professionals to provide not just resumes, but also insightful, consultative information about the market in general. With over 35 years of combined recruiting experience on a national level, we are able to leverage our contacts within each industry to provide our clients and consultants with an ideal match for both.
Role: Manufacturing Quality Assurance Specialist
Location: Melrose Park,
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