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

Certified Laboratories Inc

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