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QA Associate in Cockeysville, MD at Synerfac

Date Posted: 12/27/2018

Job Snapshot

Job Description

Our client is a science-driven contract development and manufacturing organization providing services to the global pharmaceutical industry, and they are a leader in pharmaceutical product development. They are currently looking for a Quality Assurance Aseptic Associate.The successful candidate will witness and verify the QA functions related to the manufacturing of sterile products while adhering to written guidelines. They will also ensure that the day-to-day tasks of the QA Unit supports the overall business plan while maintaining the highest quality products, ensuring the safety, identity, strength, purity, and quality that the drug is purported to possess.Other responsibilities include the following:
• Performing “Line Clearance” and “Cleaning Verification” for manufacturing and packaging operations per established Standard Operating Procedures (SOPs) and Batch/Packaging and Labeling Records’ requirements
• Performing in-process sampling, inspections, testing, and batch record reviews during manufacturing and packaging operations
• Performing Acceptable Quality Level (AQL) sampling for in-process and finished product
• Participating in the preparation for sampling, actual submission of samples to Quality Control and Micro lab, and disposition of samples for Cleaning Verification
• Inspecting cGMP areas for compliance to policies and procedures as written approved
• Performing daily systems verifications including, but not limited to, recording and reporting of agnehelic gauge data and water system data and the disposition of the systems
• Conducting investigational activities and preparing Incident Reports, Investigation Reports, change controls as assigned
• Understanding quality systems (including policies and procedures), and recommending improvements affecting compliance and efficiencies
• Performing Master and Batch Production Records Review (Aseptic Manufacturing)
• Assisting with the review of validation protocols, raw data and reports