QA Operations Specialist (15-month contract)
Core
Ensure clinical batches meet cGMP standards by authoring, reviewing, and maintaining documentation for drug manufacturing and testing activities.
Role type
QA Operations Specialist (Contract)
Builds
Clinical batches for antibody-based medicines in endocrinology, women's health, immunology, and oncology
Domain
Biotechnology / Clinical Manufacturing / Quality Assurance
Deliverable
physical/clinical work
Required skills
cGMP knowledge, batch record review, deviation investigation, CAPA management, change control, risk assessment, internal auditing, data integrity, regulatory compliance (FDA, Health Canada, EU, ICH)
Preferred skills
Analytical sciences background, ERP materials release, facility inspection readiness
Technologies
ERP systems, electronic batch records
Responsibilities
Provide quality support for GMP Quality Control and Drug Substance manufacturing operations; Review GMP documents and raw data for compliance; Support review of batch records from external operations; Perform ERP materials release; Develop and revise quality procedures; Participate in quality events (deviations, investigations, CAPAs, change controls); Conduct risk assessments; Maintain facility inspection readiness; Perform internal audits.
Seniority
Mid-level, hands-on IC
