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Manufacturing Quality Assurance Specialist

Pinpoint Pharma Melrose Park Full-Time
$17.00 - $19.00 / hour
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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.

Job Description:

  • 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.

  • Performs additional duties and responsibilities as delegated by MQA Disposition Supervisor, Manager, or Director of Quality Control.

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. 

  • Previously worked in Quality, Manufacturing, and/or with batch records.

Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
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Pinpoint Pharma 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.

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