Senior Quality Specialist

Job Description

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