Quality Assurance Specialist

Job Function

The Quality Systems Specialist is primarily responsible for the following:

• Designs, develops, and implements internal auditing programs and procedures consistent with the organization’s requirements
• Performs Internal Audits, to ensure that procedures are available and adhered to according to requirements for maintaining ISO/IEC 17025:2017 accreditation and GLP (Good Laboratory Practices) recognition.
• Performs GLP inspections to ensure that GLP studies are completed according to OECD and/or FDA GLP requirements.
• Reports audit findings to Director QA or designate and conducts post-audit meetings as necessary.
• Performs/ reviews non-conformance investigations to ensure the non-conformance has been addressed and full and proper resolution has been documented.
• Issues corrective actions in response to Quality Systems activities, tracking the progress and verifying the implementation and effectiveness of corrective actions
• Completes evaluation of supplier quality
• Arranges and prepares for external audits, assists with pre and post-assessment activities. Coordinates necessary action on audit findings corrective/preventive actions, and responds to related findings externally.
• Reviews/ Evaluates laboratory performance in Proficiency testing/ Inter-laboratory studies
• Coordinates/ performs refresher training (ISO 17025 and GMP) for laboratory staff.
• Reports quality metrics regularly to top management
• Responsible for quality projects as assigned

Primary Responsibilities

• schedule and perform internal audits
• Participate in external audits
• review and investigate non-conformances, client complaints
• Issue and monitor corrective actions
• Evaluate supplier quality
• Review, approve, and maintain equipment qualification records
• Perform Administrative Tasks
• The employee shall implement the Laboratory Quality Policy and perform their duties in accordance to existing job specific requirements and procedures
• Compliance to Health & Safety policies and procedures; wear required Personal Protective equipment at all times while in the laboratory
• Other duties as assigned

Education

• Minimum Bachelor of Science in a technical discipline (Chemical or Biological Sciences)

Experience

• 3+ years experience in an auditor role in ISO 17025 accreditation, GLP and/or GMP regulated environment, with proficiency in quality assurance systems and documentation
• Excellent attention to detail, organizational, prioritization and problem-solving skills
• Technical experience in the use, calibration of various analytical instrumentation commonly found in a commercial laboratory.
• Proficient in written and spoken English. excellent communication, conflict resolution
• Proficient in MS Office (Excel, Outlook, Word); Computer literate. Familiarity with IT systems, electronic submission systems, data and document management system
• Or as determined by Human Resources and Department Manager/Supervisor