Quality Assurance Specialist III

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $10 billion, we have more than 30,000 employees and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer. If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific. Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer. Job Description Quality Assurance Specialist III Position Summary:  Serve as a focal point for the Quality Assurance organization, responsible for the coordination and execution of core QA functions with limited oversight from the Director of Quality Assurance, e.g. Product Improvement Reports (PIRs) and Quarantine, Recovery and Customer Recovery and Advisories (QRRs).  Become well versed in all aspects of the QA job functions, e.g. processing of PIRs, QRRs, customer surveys, SalesLogix tickets, weekly metrics, etc.  Serve as PIR process champion.  Supervise daily PIR download and distribution.  Identify those PIRs requiring escalation.  Work with the customer to fully document the event and facilitate the return of product to be evaluated.  Coordinate internal investigations with suppliers, and communicate root cause and corrective actions to customers.  Execute QRRs requests including those that may be sensitive in nature for regulatory or legal reasons.  Drive continuous improvement of the PIR and QRR processes, using PPI (Practical Process Improvement) as necessary.  Ensure related procedures and training materials are kept up to date.  Track team performance, and ensure that all escalated PIRs and QRRs are completed in a timely manner.  Collect and analyze quality data, run Oracle queries, and prepare and distribute the Quality dashboard.  Visit vendors as required to bring attention to and resolve quality related issues.  Lead efforts to create and revise QA policies and procedures.  Ensure that all customer surveys and RFPs (Request For Proposal) are responded to in a timely manner.  Train and mentor members of the QA team.  Present the QA function and provide basic training at Sales On Boarding class.  Other duties as assigned.   Minimum Requirements/Qualifications:   Attention to detail. Ability to multi-task. Customer focused. Flexible team player. Excellent oral and written communications skills. Experienced in dealing with customers, suppliers, and senior management. Skilled problem solver with a results orientation. Experienced leader or project manager of cross-functional teams. Strong computer and technical skills, including: data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, and Oracle. Experienced in a continuous improvement methodology or related analysis tools, e.g. Six Sigma, PPI, run charts, flow charting, Pareto charts, pivot tables etc. Experience working in an ISO and/or FDA cGMP environment. Bachelors Degree or equivalent experience in a technical/scientific field, e.g. engineering, chemistry, biology, or mathematics. Minimum of five years experience in a regulatory, quality assurance/control, laboratory, or operations environment. Ability to travel and work in a laboratory or manufacturing environment; less than 15% of the time. Non-Negotiable Hiring Criteria: Experience in dealing with customers, suppliers, and senior management Strong computer and technical skills, including:  data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint, and Oracle. Experienced leader or project manager of cross-functional teams Experience working in an ISO and/or FDA c GMP environment Bachelors Degree or equivalent experience in a technical field, e.g. engineering, chemistry, biology, or mathematics.Education: BachelorsJob Level: Experienced