Teams at Pace Labs

Reviews and verifies GMP analytical QC data, chromatograms, calculations, and test records for accuracy, completeness, data integrity, and regulatory compliance. Conducts trend analysis and supports OOS, OOT, deviation, CAPA, and change-control investigations. Maintains QC testing trackers, documentation workflows, and validated repository records while supporting batch release, audits, capacity planning, and cross-functional project timelines.

The Quality Analyst supports laboratory quality programs by reviewing quality documentation, analyzing trends, tracking equipment calibration, participating in audits and corrective actions, and supporting training. The role applies quality policies and regulations, maintains records and databases, prepares metrics, and collaborates with laboratory teams to resolve discrepancies and improve processes. Work is performed in both laboratory and office settings.

Leads global CMC regulatory strategies and authors regulatory submissions, including INDs, IMPDs, CTAs, amendments, and annual reports. Prepares Module 2 and 3 summaries, stability reports, comparability protocols, and responses to global health authorities. Develops compliant regulatory processes and workflows while managing multiple deliverables and timelines.