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Quality Control Technical Document Specialist I
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- The Quality Control Technical Document Specialist I will author, edit, review, evaluate, and maintain GMP documentation (RM documents, FP documents, Analysis SOPs, Validation Protocols, Technical reports, etc.
- The individual will co-ordinate with Document Control and Change Control reviewers from the document's initiation to the approval stage.
- Draft Instrument SOPs, Analysis SOPs, Method Validation/Transfer Protocols/Reports, Component Specifications, Risk Assessments, and Memos.
- Coordinate with QA to perform Gap Assessments on current ARI documents against USP resources (general chapters/monographs).
- Bachelor's degree in microbiology, Chemistry, Pharmaceutical Science, or related field required.
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