QA Specialist II
Core
Ensure cGMP compliance and product quality for PDS Products and services through room clearance, documentation review, and environmental monitoring.
Role type
Quality Assurance Specialist (Pharmaceutical/Medical Device Manufacturing)
Builds
PDS Products and PDS Services
Domain
Pharmaceutical/Medical Device Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, validation activities, applied statistics, quality investigations, data-driven analysis
Preferred skills
STEM degree, process validation experience
Technologies
Microsoft Office (Word, Excel, Access)
Responsibilities
Perform room clearance activities before and during manufacturing campaigns, Review manufacturing documentation and perform final disposition of raw materials and batch records, Review room cleaning logs and supporting documentation for GMP compliance, Review analytical data supporting site utilities including WFI and clean steam, Review environmental monitoring data to ensure cleanroom compliance, Review and approve change control documentation, Provide on-the-floor QA support during manufacturing campaigns, Lead product quality and quality system improvement initiatives using data-driven analysis
Seniority
Mid-level, hands-on IC
