Overview
Quality Assurance Specialist Jobs in Sacramento County, CA at GeminiBio
Title: Quality Assurance Specialist
Company: GeminiBio
Location: Sacramento County, CA
Draft, review, and update stability protocols upon revisions to specifications, or regulatory requirements
Generate/review stability study summary reports and verify associated source data
Own investigations pertaining to OOS and OOT stability results and/or deviations
Perform impact assessment of temperature/humidity excursions
Escalate to Quality management any out-of-trend or out-of-specification data immediately upon discovery
Accurately document all activities with adherence to cGMP and company standards
Work with computers as well as laboratory software, or proprietary software as needed
Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to management
Write, revise, and/or review Standard Operating Procedures (SOPs)
Adhere to SOPs and GMP regulations and policies
Support internal and external audits as required
Meet productivity standards without sacrificing quality and safety
Adhere to established safety procedures; use equipment and materials properly
Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual
