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SGS is the world's leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
The Senior Quality Assurance Specialist duties are geared toward assisting Quality Assurance Management in administering the company's quality system. This is accomplished through internal audit performance and reporting, Operations Manual System management, Form Control System management, and participation in various quality improvement projects. Overall, the Senior Quality Assurance Specialist position presents the employee with an opportunity to both learn the skills required to advance in the management field of quality assurance and at the same time play a crucial role in the company's long-term success.
This position presents the employee with an opportunity to contribute first-hand to the process of providing quality data to SGS customer base.
The Senior Quality Assurance Specialist in the Quality Assurance Unit at SGS Life Science Services reports to Quality Assurance Management or the QA Team Leader.
OUR PROMISE TO OUR CUSTOMERS
At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.
SERVICE RESPONSIBILITIES TO CUSTOMERS
• Participate in the approval of Out of Specification events, deviations, and special assessments to ensure compliance to current regulatory standards.
• Participate or oversee the approval of routine testing, special projects, validation projects, or other specialized studies to ensure successful completion in a timely and effective manner.
• Assist in handling company complaints in an efficient and timely manner.
• Respond to all customer requests for information pertaining to regulatory and compliance issues in a timely and accurate manner.
• Play a lead role in departmental and/or company-wide projects designed to improve customer service.
• Assist Management in addressing and resolving Corrective or Preventive actions.
• Assist in the conduct of customer audits and in writing responses to audit reports.
SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
• Assist the Team Leader or Quality Assurance Management in fielding questions and resolving issues that arise internally within the Quality Assurance team.
• Provide updates to Quality Assurance Management concerning assigned projects.
• Assist the Team Leader or Quality Assurance Management in coordinating the training program and providing training within the Quality Assurance team.
• Play a lead role in becoming a key department source on regulatory issues both to laboratory personnel and internally within the Quality Assurance team.
• Assist Senior Management in administering the company's Quality Planning effort.
• Assist Quality Assurance Management in audit planning, performance, follow-up procedures, and/or corrective action.
• Respond to all reasonable staff requests for information pertaining to regulatory affairs.
• Assist in the performance of the internal audit program.
• Maintain thorough knowledge and understanding of all general SOPs pertaining to the laboratory.
• Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory.
• Assist in the review and approval of deviation notices and investigations generated by technical departments.
• Assist management is overseeing the investigation system for all technical departments.
• Assist Management in auditing specific aspects of the company's ISO quality systems, report all findings to senior management, issue corrective action plans, and verify effective corrective action.
• Assist Management in core GLP functions as they relate to Quality Assurance.
• Assist Management in the review and approval process for company SOPs.
• Assist Management in maintaining the company's Change Control System.
• Assist Management in assigned Quality trending.
• Approve and issue Certificate of Analysis and sign on cGMP related reports.
"In the course of employment, you will be required to travel to and/or work at a client site. The company requires employees to be vaccinated against COVID-19 in order to travel commercially and many clients require visitors performing work at their locations to be vaccinated. Therefore, this role requires a candidate who is fully vaccinated or will be prior to an anticipated start date. The successful candidate will be required to provide proof of having received a COVID-19 vaccination.
The company will provide a reasonable accommodation upon request after an offer is extended."
• Must be able to think critically; problem-solving skills essential.
• Knowledge of and familiarity with word processing and database software required.
• Advanced language proficiency (fundamentals of grammar and syntax) required.
• Solid organizational skills required; must be able to prioritize multiple tasks.
• Must be able to obtain and assess objective evidence fairly.
• Strong communication skills (written and verbal) essential.
• Must be able to communicate complex ideas in relatively simple terms.
• Strong leadership skills required; must be able to form consensus among others.
• Must be able to work with persons from diverse backgrounds.
• Must be able to obtain and assess objective evidence fairly.
• Safety is a top priority within SGS. Every employee within the organization has defined HSE Duties and Responsibilities to ensure that the organization meets its objectives of no harm to personnel, damage to equipment, or harm to the environment.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.
• This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
• SGS is an Equal Opportunity Employer.