The role supports critical logistics center operations including goods receipt, sampling, and drug substance put away within a next-generation manufacturing facility
Job Summary
The role supports critical logistics center operations including goods receipt, sampling, and drug substance put away within a next-generation manufacturing facility.
Candidates must oversee quality assurance aspects of material receipt and batch disposition in strict accordance with GMP regulations and internal procedures.
The position requires active participation in regulatory inspections, internal audits, and the resolution of deviations and CAPAs related to materials.
Matching Summary
The role supports critical logistics center operations including goods receipt, sampling, and drug substance put away within a next-generation manufacturing facility.
Skills & Requirements
Must-have
GMP regulatory compliance knowledge
Material batch disposition experience
Deviation and CAPA investigation skills
Change control review capabilities
SAP and QMS software proficiency
Nice-to-have
Cross-functional collaboration abilities
Continuous improvement initiative support
Strong written communication skills
Fast-paced environment adaptability
Regulatory inspection participation
Key Requirements
Level 7 qualification or higher in Science or Engineering
Minimum 3 years relevant QA experience in pharma/biotech
Experience with SAP, Trackwise/Veeva, and MES systems