Associate Lead I - Biomanufacturing Compliance, Lead Investigator
Core
Author and revise deviation records, preventative actions, and cGMP documents while ensuring timely and accurate completion in a biologics manufacturing facility.
Role type
Associate Lead I - Biomanufacturing Compliance, Lead Investigator
Builds
Biopharmaceutical drug substances via mammalian cell line engineering and flexible single-use systems
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Deviation writing, Root Cause Analysis, Corrective and Preventive Action (CAPA), cGMP principles, SOP authoring/editing, Quality systems proficiency (TrackWise, ComplianceWire, JD Edwards, Unicorn), Manufacturing operations knowledge
Preferred skills
Large-scale upstream or downstream manufacturing experience for biological drug products in GMP environment
Technologies
TrackWise, ComplianceWire, JD Edwards, Unicorn
Responsibilities
Author and revise deviation records and cGMP documents; Track and monitor open investigations; Engage in process compliance culture initiatives; Participate in Inspection Readiness activities; Provide guidance on Standard Operating Procedures; Assist in supporting internal and client audits
Seniority
Mid-level, hands-on IC