QA Data Reviewer - Eurofins BioPharma Product Testing Toronto, Inc.
Core
Ensuring compliance with GMP, Health Canada, and FDA regulations by reviewing laboratory batch data, method validations, and instrument qualifications for clients.
Role type
QA Data Reviewer
Builds
Compliance reports and validation packages for pharmaceutical and life science clients
Domain
Life Sciences / Pharmaceutical Testing / GMP Compliance
Deliverable
client delivery
Required skills
GMP compliance knowledge, chemical analytical report review, HPLC/GC/UV/wet chemistry data review, data integrity procedures, SOP adherence, investigation judgment, troubleshooting
Preferred skills
MS Office proficiency, independent work, multitasking, attention to detail
Technologies
HPLC, GC, UV, MS Office (Outlook, Word, Excel)
Responsibilities
Perform data review of laboratory batches including raw data and calculations; Review method validation and transfer projects; Prepare and review instrument qualification protocols; Ensure GMP compliance and data integrity; Verify results are within specification; Troubleshoot and respond to problems
Seniority
Mid-level, hands-on IC
