Participate in the generation and revision of controlled and project documents; author, review, edit, and approve controlled documents (including procedures, methods, and forms related to quality systems and to manufacture and testing of product) and project documents (including protocols and reports related to development, validation, and stability). Key Responsibilities: Author, review, edit, and approve discrepancy reports including, but not limited to, reports for deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.