Quality Assurance Specialist, SF 150798
Core
Provide quality and technical support to the production team by overseeing manufacturing rooms and laboratories, reviewing and approving data and Quality Management System documentation.
Role type
Quality Assurance Specialist (Manufacturing)
Builds
Pharmaceutical and medical device products (PDS Products, PDS Services, MDS operations)
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 documentation review, batch record review, environmental monitoring data analysis, change control management, data-driven quality improvement analysis, applied statistics, quality investigations
Preferred skills
STEM degree (Chemistry, Biology, Engineering), FDA cGMP and QSR knowledge, process validation experience, Microsoft Office proficiency
Technologies
Microsoft Office (Word, Excel, Access)
Responsibilities
Perform room clearance activities to ensure cGMP compliance; 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 (WFI, clean steam, nitrogen); Review environmental monitoring data to ensure cleanroom compliance; Review and approve change control documentation; Provide on-the-floor QA support during manufacturing campaigns; Provide on-call quality support to address manufacturing issues; Lead product quality and quality system improvement initiatives using data-driven analysis
Seniority
Mid-level, hands-on IC
