About this role
Job Responsibilities
- Provides direct QA oversight of clinical small molecule drug substance and oral solid dosage (OSD) pilot plant manufacturing, warehouse, and is responsible for product disposition utilizing risk-based and phase appropriate approach.
- Reviews and approves manufacturing documentation which may include batch records, product release documentation, deviations, investigations (i.e. OOS, OOT, atypical), CAPAs, change controls, protocols and reports.
- Maintains accurate, complete, and timely (ALCOA) quality records in accordance with GMP and quality systems.
- Supports QA team members in daily operations such as lot disposition and process improvement projects.
- Participates in departmental and cross-functional projects, delivering assigned QA deliverables in compliance with quality systems.
- Supports small to moderately complex process improvement projects.
- Applies root cause analysis and uses risk-based thinking to support investigations and quality events.
- Helps identify data trends, anomalies, and potential compliance risks and escalates appropriately.
- Leads revisions of GMP documentation to support QA projects.
- Creates metrics and reports as needed.
- Supports regulatory inspections, internal audits, including preparation, execution, and observation response generation.
- Assists junior staff with day-to-day tasks as an SME.
- Authors, reviews SOP’s, protocols, reports and other GMP documentation.
Knowledge:
- Demonstrates proficiency in Good Manufacturing Practices (GMPs).
- Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
- Demonstrates thorough knowledge of FDA / EMEA sta