
Specialist - QA Release
Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards. Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP. Resolves major issues that are not defined by SOP. Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release. Performs review and approvals of APHIS Form 2008s against applicable Outlines of Production for submission to the USDA for all serial releases. Performs review and approvals of significant change controls (new facility/new equipment/new product). Performs assessment and approvals of requests for items that are returned to stock.
5 years of relevant experience is required
Excellence in comprehension/application of USDA and EU regulatory requirements for production and distribution of regulated biological articles
Strong theoretical and practical knowledge of regulated processes and one technical discipline
Documentation
Time Management
MS Excel
MS Word
SAP ERP
Process Improvement
Communication Skills
Adaptability
Results-Driven
Multi-tasker
According to JobzMall, the average salary range for a Specialist - QA Release in 2621 N Belt Hwy, St Joseph, MO 64506, USA is $63,477-$98,943. This range is based on the average salaries of individuals in similar roles in the same area.
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C.H. Boehringer Sohn AG & Ko. KG is the parent company of the Boehringer Ingelheim group, which was founded in 1885 by Albert Boehringer in Ingelheim am Rhein, Germany. As of 2018, Boehringer Ingelheim is one of the world's largest pharmaceutical companies, and the largest private one.

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