Quality Assurance Specialist
- Full-time
Company Description
About SGS:
Make an impact with SGS! With more than 97,000 employees and 2,600 offices and laboratories across the world, SGS is a silent force working hard behind the scenes to deliver quality and integrity to businesses across nine industries. As the world’s leader in providing inspection, verification, testing and certification services, Forbes ranked the SGS Group as one of the world’s top multinationals and one of the world’s most innovative companies. The Dow Jones Sustainability Index has also recognized the SGS Group for its sustainability processes. In Canada, SGS employs over 2,000 team members across 70 locations.
Job Description
This position is responsible for the continued administration, supervision and monitoring of the adherence of the laboratory operations to the Quality Management System policies and procedures set up by Agriculture and Food Management.
This position provides guidance, advises and assists the Agriculture and Food operations on their practices with respect to the requirements of the quality management system, applicable regulatory and international standards (e.g. ISO, GLP, GMP), and for any special program certifications. As directed by the Quality Assurance Manager, this position also provides quality assurance and regulatory leadership to ensure suitable compliance approach across the Agriculture and Food trade and laboratory operations.
This position also provides coordination, development and implementation of Quality Systems/Programs necessary to assure compliance with applicable Canadian, US and international standards and regulations (i.e. GMP, GLP). Carries on QAU functions entirely separate and independent of the personnel engaged in the direction and study conduct.
RESPONSIBILITIES
- Monitor and review testing records, and quality control performance including Quality Control Charts with respect to trends and biases as well as verification processes within the laboratory operation.
- Monitor and maintain the quality system improvement programs to ensure continual improvement. Propose strategies for the development and operation of the laboratory to meet the quality requirements.
- Guide and support investigation of out-of-specifications, non-conformance's, customer complaints and determination of corrective actions.
- Prevent release of any report, Certificate of Analysis, or information to the customer when a deficiency is identified during a technical audit.
- Identify areas of quality risk for the area of responsibility, and any major technical non-conformances are brought to the attention of the Quality Assurance Manager and Branch/Lab Manager.
- Maintain and keep current thorough knowledge and understanding of applicable international standards, guidelines and regulations pertain to work performed in the laboratory such as but not limited to ISO/IEC 17025, OECD GLP and cGMP.
- Coordinate, develop and implement Quality Systems/Programs in conjunction with the Quality Assurance Manager necessary to assure compliance with applicable Canadian, US and international standards and regulations (i.e. OECD GLP, cGMP, ISO/IEC 17025)
- Identify needs and ensure development for SOP’s, checklists, templates, forms, and other QAU documentation for critical areas of operation.
- Review and approve SOPs, forms and other quality documents. Assignment and tracking of logbooks, and ensure appropriate document controls measures applied to all quality documents.
- Ensures compliance to the SOP’s and applicable standards and/or regulations and no deviations from SOPs and approved protocols were made without proper authorization and documentation.
- Provides SOP training, and internal regulatory training.
- Provides direction to the laboratory personnel and organizes site-specific responses to regulatory agency and client inspections and corrective action commitments in a timely manner.
- Monitors supplier performance and approved subcontractor for testing. As needed, audits contract facilities for compliance with applicable standards and/or regulatory requirements.
- Review method validation, measurement uncertainty spreadsheets, and approval.
- Work on special projects as assigned by the Quality Assurance Manager and/or Branch/Lab Manager.
Responsibilities in GLP Compliance:
- Maintains the copies of all protocols (study plans) for studies conducted at SGS test facilities.
- Conduct inspection of GLP regulated studies, to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in conformance with applicable company and regulatory requirements.
- Ensures that each GLP study was inspected at adequate intervals to assure the integrity of the study and maintains written and properly signed records of each inspection.
- Ensures that any problems and findings are promptly brought to the attention of the principal investigator/ study director and management.
- Ensures that no deviations from approved protocols and SOPs were made without proper authorization and documentation.
- Reviews the final study reports to assure that they accurately describe methods outlined in protocol and SOPs and that the reported results accurately reflect the raw data of the study.
- Ensures that the Quality Assurance Statement was prepared and signed to be included with a final report.
- Performs GLP Archivist duties when designated.
Qualifications
- B.Sc. (chemistry or biology) or Diploma (chemical sciences preferred) from a recognized technical institute.
- Supervisory experience plus 3-5 years related experience in an environmental, pharmaceutical, and/or biotechnology industry, having direct responsibility for quality assurance, and/or regulatory affairs with a strong emphasis on ISO/IEC 17025, GLP and cGMP and international regulations, or equivalent combination of education, training, and experience.
- Experience with Quality Assurance Principles and Quality Control Procedures. Active membership of a professional organization specific to quality assurance and/or federal regulations (e.g. SQA. ASQ, GLP, etc) is an asset.
- Experienced and deep understanding of quality assurance and quality control programs (e.g. ISO, GLP, GMP).
- Ability to lead in accreditation process for lab including but not limited to Health Canada, CFIA, ISO/IEC 17025.
- Up-to-date and sound knowledge of ISO/IEC 17025, OECD GLP, cGMP requirements and practices
- Competent in reviewing analytical procedures and practices.
- Familiar with official accredited methods such as AOAC, AOCS and USP methodology.
- Strong science background and experience in laboratory practices.
- Ability to work with a high degree of accuracy.
- Excellent report writing and technical writing skills.
- Ability to manage complex projects to successful completion.
- Ability to conduct training sessions or presentations for large groups of internal or external customers.
- Familiar with Agricultural and Food matrices.
Additional Information
SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process. Accommodations are available on request for qualified candidates during each stage of the recruitment process.
Please note that candidates applying for Canadian job openings should be authorized to work in Canada.