Quality Assurance Specialist

Job Summary:

Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis.  Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits.

Essential Duties/Responsibilities:

• Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
• Maintain the internal auditing program to ensure the established techniques are followed and understood.
• Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings.
• Maintain the Management Review process.
• Maintain the laboratory proficiency testing program.
• Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.) and train
  laboratory personnel, as needed to help reduce quality events.
• Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings.
• Support quality event investigations to completion using formal root cause analysis tools.
• Support periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the QMS.
• Maintain the list of approved suppliers and subcontractors.
• Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.).  Serve as site contact for all quality inquiries on analytical reports and related documentation.
• Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
• Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other site-specific Quality Assurance documents.
• Create, revise, review, and approve newly written documents and document revisions.
• Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements.
• Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines.
• Exist as a backup for all other Quality Assurance personnel.