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Quality Associate I · Beltsville, MD
1) Review documentation for accuracy and compliance to procedures, and release or reject as appropriate. Obtain resolution on areas identified as non-conformance. Interpret and evaluate results in terms of acceptability to standads, procedures and regulatory requirements.
2) Prepare and issue reports. Manage database including all QA personnel with the use of the Access program (trouble shooting, etc.) and modifications to the databases such as creating new reports, queries, forms, tables, etc.
3) Coordinate Release Testing of product with the Analytical group.
4) Initiate and obtain applicable approval for inventory and test requests.
5) Prepare and issue Release Testing Result Report.
6) Proof read new or revised procedures for accuracy.
7) Conduct analysis of written procedures and submit procedural changes as needed to meet Corporate, Divisional, and Regulatory Requirements.
8) Participate in internal or external assessments, as required. Support process with timely closure of observations/audit items.
9) Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.). Identify areas of non-conformance and inform management.
10) Provide...
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