Quality Assurance Specialist,
Core
Provide quality and technical support to production teams by overseeing manufacturing rooms and laboratories, reviewing and approving data and Quality Management System documentation.
Role type
Quality Assurance Specialist (Manufacturing)
Builds
Manufacturing batch production records, analytical data, engineering/manufacturing/validation documentation, and cleanroom compliance.
Domain
Pharmaceutical/Medical Device Manufacturing
Required skills
cGMP compliance, batch record review, analytical data review, environmental monitoring, change control management, quality system documentation, problem-solving, applied statistics
Preferred skills
STEM degree (Chemistry/Biology/Engineering), validation experience, data-driven analysis, continuous improvement
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 for GMP compliance; Review analytical data for site utilities (WFI, clean steam, nitrogen); Review environmental monitoring data for cleanroom compliance; Review and approve change control documentation; Provide on-the-floor QA support during manufacturing campaigns; Provide on-call quality support for manufacturing issues; Lead product quality and quality system improvement initiatives; Analyze quality metrics and support continuous improvement projects.
Seniority
Mid-level, hands-on IC
