Assistant Scientist I, Quality Assurance

Puresyn
Malvern, PA

Job Description

Job Description

Salary: $45,000 per year

  • 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.
Posted 2026-06-25

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