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Analyst I, Quality Assurance
Location:
Winnipeg
Description:
Those who join Emergent Bio Solutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The Quality Assurance Analyst I, reports to the Manager of Quality by ensuring the primary objective of batch record review and on the floor activities are effective and in compliance with regulatory requirements Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Batch Record Review Review all batch documentation in accordance to governing procedures. This includes but is not limited to commercial and clinical manufacturing, Tech Transfer and Engineering runs. Resolve errors and/or discrepancies in a timely manner and ensure appropriate action is taken. Escalate any concerns or potential non-conformances to Supervisor and/or Manager Compile and collate batch documentation packages Prepare Release Protocols for submission to regulatory agencies Perform ERP transactions associated with lot release; physically identify lot status Commercial Product Distribution Review shipment documentation in accordance to governing procedures. This includes shipments pertaining to commercial (licensed) distribution and excludes all clinical and unlicensed shipments. Ensure all requirements have been met for QA release of the product shipment. This includes but is not limited to review against applicable Quality Agreements and/or contracts associated with the shipment. In addition, ensuring there are no regulatory restrictions on the product being shipped. Other Activities: Floor QA activities – monitor production, quality control and other support areas for compliance with procedures and GMP Support coverage of operational activities outside of core. Visit ListedBuy for more information.
Company:
Emergent Biosolutions
Posted:
January 27 on ListedBuy
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More About this Listing: Analyst I, Quality Assurance
Analyst I, Quality Assurance is a Other Art & Media Jobs QA Job at Emergent Biosolutions located in United States. Find other listings like Analyst I, Quality Assurance by searching Oodle for Other Art & Media Jobs QA Jobs.
Analyst I, Quality Assurance is a Other Art & Media Jobs QA Job at Emergent Biosolutions located in United States. Find other listings like Analyst I, Quality Assurance by searching Oodle for Other Art & Media Jobs QA Jobs.