When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact/
This position will be responsible for managing the complaint and corrective action (CAPA) systems and processes for Thermo Fisher Scientific Laboratory Chemicals, site in Ward Hill, MA. The successful candidate will be coordinate all aspects of this exception system including investigation lead, CAPAs generation, KPI development/reporting, status tracking, and system training. This role will serve as primary contact for site and external customers driving timely closure and ensuring final documentation is provided to customers for their records. Duties also include participating in internal and external audits, contributing to FMEA assessments, and driving process improvement. Candidate must be a self-starter and able to work with minimal direct oversight.

What will you do?

• Manage Complaint System (Trackwise), which includes:
  • Review all complaint submissions via central inbox and coordinate investigation assignments with Technical Services, Operations, support teams
  • Track and report status and metrics to ensure timely and effective closure
  • Verify effectiveness of completed CAPAs
  • Act as primary liaison with customers and internal support groups to meet related customer documentation and closure requirements
• Serve as site investigation lead and SME by developing and providing training on investigative tools such as 5-Whys, fishbone diagrams, and brainstorming
• Partner with Operations to co-lead complex and priority investigation and process improvement related initiatives and forums
• Participate in/co-lead customer and ISO 9001 related registrar audits including coordinating preparation activities, SME interviews, and response preparation
• Lead/participate in site process improvement projects (PPI/Lean) and QMS related projects to address deficiencies, foster system enhancement, or compliance to corporate requirements
• Updates and develops procedures and work instructions, as necessary to ensure conformance with ISO 9001.
• Perform other duties as assigned.

How will you get here?
Education

• Bachelor’s Degree in Chemistry, Biology, or Engineering or equivalent

Essential Skills and Experience:

• At least 2 - 4 years of experience with Quality in an ISO 9001/GMP regulated manufacturing environment with 1 years of experience as functional lead/SME of complaints, exception, or CAPA system
• Proficient knowledge of Quality Management Systems particularly with complaint, exception, and CAPA systems in accordance with ISO 9001: 2015 and/or GMP standards.
• Experience with QMS software such as Trackwise, Agile, SuccessFactors, and MasterControl preferred
• PPI/OEx-Lean production system experience
• Proven track record of hands-on problem solving expertise in a manufacturing environment.
• Proficiency of Excel, Word, PowerPoint, including data analysis and statistical methods.
• Strong communication skills and ability to present to various levels of internal and external stakeholders.
• Strong technical writing skills for investigations
• Skilled at Key Performance Indicator (KPI) development, trending, and site-based reporting to demonstrate performance and improvement opportunity areas
• Ability to manage numerous priorities and activities in parallel (project management)
• Strong collaborative and “people skills” to be able to deal with various personalities and levels within and outside of the organization
• Strong written and verbal communication skills
• Excellent organizational skills and must be detail oriented.

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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