Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate
Perform internal quality assurance audits
Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes
Perform review and approval of SOP's
Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretations
Provide information and revision support for updating company publications including quality policy manuals, company web site, and newsletters
Identify and drive system improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity
Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reports
Perform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolution
Review QC data and non-conformance issues for assigned technical groups, evaluate for trends or patterns
Investigate and document QA, method, and regulatory deficiencies within the lab; take investigation to next level when needed; diagnose and solve problems independently
Implement and document computer program changes, review computer system documents, provide feedback to meet regulatory and industry expectations