Thermo Fisher Scientific Quality Engineer-CAPA in Bridgewater, New Jersey
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.
Laboratory Chemicals Division (LCD) is part of the Life Sciences Solutions Group (LSG) and provides smart chemistry solutions for the pharmaceutical, agrochemical, diagnostic, detection, electronic, fuel cell, paints and coatings markets. This role can be based at either our Bridgewater, NJ or Fair Lawn, NJ facility but there will be occasional travel between the two facilities.
How will you make an impact?
This role will ensure compliance to the Corrective and Preventative Action (CAPA) process by serving as a subject matter expert to different cross-functional groups. You’ll also drive continuous improvement activities specific to the CAPA process.
What will you do?
Facilitate and manage CAPA investigations for customer complaints, recurring NCR’s, audit non-conformances, and other investigations using problem solving methodology to identify root cause and implement effective corrective action.
Conduct CAPA effectiveness verification using risk management tools to evaluate impact of changes.
Perform duties in accordance with quality system to resolve customer complaints.
Recommend and implement enhancement to the quality system that result in improved corporate quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs.
Analyze trend data, process capability data and other quality metrics in order to proactively propose specification or process changes. Present findings and recommendations to Quality Management team.
Participate in PPI (Practical Process Improvement) and projects to support achievement of quality and business metrics.
Support Quality Assurance in validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectiveness.
Represent Quality Assurance during change management activities, including configuration management, document control, and procedure control.
How will you get there?
- Position requires a Bachelor’s of Science Degree in Engineering or equivalent experience.
A minimum of 5 years of experience working with CAPA, complaints, and nonconformance’s in an ISO or cGMP environment.
Experience reviewing CAPA, complaint, nonconformance documentation.
Proven track record of hands-on problem solving expertise and driving continual improvement in a manufacturing environment.
Formal training and experience as an ISO Auditor/Lead Auditor a plus.
Knowledge, Skills, Abilities
Results oriented work attitude that exhibits initiative, energy and ability to drive change.
Excellent interpersonal skills with ability to be a team player and communicate, build and maintain relationships with internal and external customers.
Advanced proficiency of Excel, Word, PowerPoint, including data analysis and statistical methods.
Ability to travel between our two facilities in New Jersey (Bridgewater and Fair Lawn) on occasion.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
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.