Quality Engineer CAPA Specialist

Location
Bridgewater, NJ
Salary
Competitive
Posted
March 20 2017
Ref
43628BR
Position Type
Full Time

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.



Our Laboratory Chemicals business has exceptional growth potential.  Laboratory Chemicals was built from several acquisitions and provides a full range of analytical reagents and discovery chemicals to Thermo Fisher’s core research markets worldwide. Laboratory Chemicals has been identified as a strategic growth area for the company with expansion opportunities in the US, Europe and developing markets, particularly Asia. Laboratory Chemicals has 14 operational facilities in the US, Europe, and Asia, and sells a significant portion of its products through Thermo Fisher customers channels group in major Western markets



You’ll be responsible for managing the Corrective and Preventive Action (CAPA) System for Thermo Fisher Scientific Laboratory Chemicals, NJ Sites in Bridgewater and Fair Lawn. You’ll also be responsible for filing, prioritizing, assigning, assessing, approving and tracking CAPAs. Risk Analysis is a critical element to be successful in these key activities.



Responsibilities:




  • Manage CAPA System, which includes:

  • Review all CAPA submissions

  • Assess risk of CAPA submissions and initiate CAPAs

  • Assign CAPAs to owners

  • Follow up on CAPA status and commitments

  • Verify effectiveness of completed CAPAs

  • Track CAPA metrics for reporting at Management Review



  • Utilize Risk Analysis methodologies in decision making

  • Enhance current CAPA Process

  • Participate in other QMS efforts such as complaints, supplier corrective action, non-conformances, document control, training, supplier quality, etc.

  • Participate in PPI (Practical Process Improvement) events

  • Perform other duties as assigned



  • Minimum Qualifications:




    • BS in a technical field with at least 5 years of experience in a manufacturing environment. Chemistry or Chemical Engineering background is a plus. Significant experience may be considered in place of degree.

    • 3 years of active involvement in CAPA, developing and improving CAPA systems.

    • Proficient knowledge of CAPA practices in accordance with standards such as ISO9001, ISO 13485, 21 CFR 820.

    • 3 years of experience in Quality Assurance or Quality Control role.

    • Knowledge of the most recent version of ISO9001.

    • Hands on experience in using Risk Analysis methodologies in decision making.

    • Experience with excel and QMS databases required; experience with Master Control or TrackWise a plus.

    • Skilled at reporting metrics showing performance and trending; advanced data analysis skills a plus.

    • Ability to manage numerous priorities and activities in parallel (project management).

    • Ability to review current processes and implement productivity and compliance improvements.

    • Strong “people skills” to be able to deal with various personalities and levels within and outside of the organization.

    • Excellent verbal and written communication skills; ability to write reports required.

    • Excellent organizational skills and be detail oriented.

    • Candidate must be a self-starter and able to work with little direct oversight.

    • Flexible to work between our Fair Lawn, NJ and Bridgewater, NJ locations.



    At Thermo Fisher Scientific, each one of our 55,000 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.



    *IND-LPG






    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.