SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
PRIMARY RESPONSIBILITIES The primary responsibilities of this position are to ensure compliance with current Good Laboratory Practice (GLP) standards, including auditing activities for Field Research and Laboratory studies and to coordinate archiving of all GLP studies. This is a full time position located in Brookings, SD. SPECIFIC RESPONSIBILITIES The specific responsibilities of the QA Specialist are based on GLP regulations and specific requirements of SGS are further delineated in appropriate SGS SOPs. Responsibilities include, but are not limited to:
Inspect and/or audit (or monitor inspections of) critical phases of studies and maintain written and signed records of findings and corrective actions.
Review the raw data and phase/final reports to assure that reports accurately reflect the raw data of the study. Prepare and sign a QA statement to be included in the phase/final report.
Report findings to personnel involved in the conduct of the studies as required by GLP.
Conduct and report findings of facility audits within the GLP Laboratory and Field sites.
As needed, work with the GLP Technical and Development Manager and other Quality Assurance officers to qualify and coordinate contract QA activities so that a smooth workflow can be maintained to ensure all projects completed by the appropriate deadline.
Determine that all deviations from approved protocols or SOPs are properly documented and authorized.
Periodically submit to SGS Management (and the study director) status reports on each study.
Support SGS Management and team members in maintaining compliance to and interpretation of applicable regulations.
Coordinate and maintain the archiving of all study material, laboratory logs, and any other necessary material for all GLP activities
Address stewardship and APHIS compliance requirements.
Participate in adequate training to keep current of regulations and industry standards.
Assist in providing annual GLP training to laboratory and field staff and contract QA as needed.
Lead annual review and revision of SGS SOPs as dictated by regulation changes and/or client requirements.
• Ensure quality and confidentiality of client and company information and take an active role in updating the Quality System. • Assist in other areas of the company as needed. • Promote responsibility, good work habits, a positive work environment and improve customer service.
At all times, comply with SGS Code of Integrity and Professional Conduct.
BS degree or higher, and 2 years relevant experience preferred.
Proficient in Microsoft Office to include Word, Excel and PowerPoint, experience with company/client electronic notebooks preferred.
Must be extremely detail-oriented, well organized and able to work independently.
Excellent communications skills required.
Must be able to work in a fast paced environment.
• Ability to handle a variety of projects effectively, efficiently and with confidentiality.
Must have or obtain a thorough knowledge of FIFRA GLP requirements and regulatory guidelines.
Must demonstrate effective teamwork and organizational skills.
Must have a familiarity with common analytical laboratory and agricultural research practices and current industry standards in study design and auditing for GLP compliance.
Health and Safety Guidelines
Demonstrate strong commitment to SGS HSE Policies, Procedures, and Work Instructions by participating in safety meetings, completing required training, intervening in unsafe situations, refusing unsafe work, and complying fully with all applicable laws and regulations related to HSE.
Respond appropriately to emergency situations and assists other staff members in maintaining readiness to respond to emergencies within the workplace.
In accordance with the SGS HSE Management System requirements, dispose of, or direct the disposal of waste generated as part of daily work performed in a safe manner and in compliance with all waste transportation and disposal regulations and requirements.
Report all incidents (actual incidents and near misses) in accordance with the SGS Incident Reporting requirements.
Use all equipment (including safety equipment) in the manner intended and report any damaged/lost equipment to supervisor.
Maintain a safe and tidy worksite.
Maintain awareness of hazards and propose controls to supervisor, HSE Representatives or relevant client/site contact.
Actively participates in incident investigations and risk assessments as deemed necessary by SGS management.