QC Lab Technician II

Quality control lab technician performing analytical and visual testing of medical device products, environmental monitoring, and documentation in a regulated manufacturing environment. Requires cGMP/GLP experience and proficiency with laboratory analytical equipment in an FDA-regulated setting.

Responsibilities

• Conduct visual and analytical testing on incoming, in-process, and finished goods using pH, density, spectrophotometry, and gas chromatography
• Perform environmental monitoring for RODI water systems and liquid media manufacturing
• Document test results on QC reports, stability studies, and validation records; analyze data for accept/reject decisions
• Investigate out-of-specification results, prepare standards and controls, maintain equipment calibration and cleanliness
• Support continuous improvement activities and maintain inventory of QC lab reagents and supplies

Requirements

• High school diploma or GED
• Minimum 2 years cGMP, GLP, or medical device quality assurance experience
• Minimum 3 years related laboratory experience
• FDA-regulated environment experience (medical device or pharmaceutical)
• Proficiency with analytical laboratory equipment and sampling techniques
• SAP system experience
• Strong Excel, Word, and technical writing skills