FSP - QC Reviewer: Small Molecule
Core
Own and drive change controls from initiation to closure, review QC data and documentation, and support quality system activities for small molecule pharmaceutical/biopharmaceutical clients.
Role type
QC Reviewer (Change Control & Quality Systems)
Builds
Quality assurance documentation and compliance reports for pharmaceutical/biopharmaceutical clients
Domain
Life Sciences / Pharmaceutical Quality Control
Deliverable
dashboards & analysis
Required skills
Change control management, QC data review, GMP/GDP compliance, documentation writing, project management, cross-functional communication
Preferred skills
Small molecule laboratory experience, change management experience, report writing, quality systems process familiarity
Technologies
None stated
Responsibilities
Write and manage change control records, coordinate with SMEs to gather information, track progress and ensure on-time closure of change controls, review QC data and documentation, support quality system activities, draft final summaries and conclusions
Seniority
Mid-level, hands-on IC
