Assistant Scientist I, Quality Assurance
Puresyn
Job Description
Job Description
- Maintain the proper documentation related to Quality Assurance.
- Assist in Controlled Document development, editing, review and generation.
- Perform Quality Assurance review of Batch Record Documentation.
- Assist in troubleshooting all Quality Assurance issues.
- Compilation and review of Manufacturing Summary documentation for contracts by collaborator request.
- Assist in TSE/BSE request, review, filing and tracking.
- Assist in issuing, completing, and tracking Approved Order List forms.
- Assist in issuing, approving, releasing, and reviewing of contract documentation, Quality Control testing documentation, and contract plasmid products.
- Assist in assigning Lot Numbers, entering orders and issuance of Contract books and component books for contracts.
- Assist in performing the Quality Assurance tasks for approval of Controlled documents.
- Perform of New Equipment (NEW) Forms, Equipment Maintenance (EM) Forms, Vendor Maintenance Calibration (VMC) Forms, Equipment Change Order (ECO) Forms, and Equipment Relocation (ER) Forms.
- Assist in completion of Monthly Quality Audits.
- Review and approving Solution Preparation forms.
- Serve as a member of the safety committee as required.
- Assist in authoring Project Reports and Process Deviation Reports (PDRs).
- Perform dedicated components release for contracts.
- Other duties as required.
Vacancy posted 8 days ago
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