Associate Product Quality - Data Verification
Core
Individual contributor ensuring adherence to compliance practices for late-stage and commercial products by reviewing critical data and documents to confirm accuracy, integrity, and regulatory readiness.
Role type
Associate Product Quality - Data Verification
Builds
GMP-compliant data integrity and regulatory readiness for pharmaceutical products
Domain
Biotechnology / Pharmaceutical Quality Compliance
Deliverable
dashboards & analysis
Required skills
GMP principles knowledge, data verification, GMP system navigation, time-sensitive compliance management, cross-functional collaboration, document author guidance
Preferred skills
FDA and ICH regulations knowledge, cross-functional virtual team experience, Veeva/Spotfire/SampleManager LIMS familiarity, MS Office proficiency
Technologies
Veeva, LIMS, Spotfire, SampleManager, MS Office
Responsibilities
Execute transactions in GMP computer-based systems, Review and verify data in technical documents within GMP Quality systems, Navigate GMP systems to identify and validate data sources, Manage time-sensitive compliance activities across multiple teams and projects independently, Collaborate with document authors across sites and time zones to support project milestones, Provide guidance and feedback to authors of GMP documents to ensure compliance and accuracy
Seniority
Associate, individual contributor