Thermo Fisher Scientific Quality Specialist II in Canoga Park, California

Job Description

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.

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

South San Francisco / Transplant Diagnostics (TDX)

How will you make an impact?

The Quality Specialist II will monitor/address/track quality issues that arise from Unplanned Deviations (UDR), Customer Inquiry (CI/COMP), Non-Conformance (NCR) or from Internal/External quality system audits. This position will assist the QA Supervisor and product line/QS process owners with Corrective/Preventive action (CAPA) projects to ensure timely and effective completion of required activities.

What will you do?

· Responsible for the management and closure of UDRs, NCRs, COMPs

· Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory)

· Responsible for the assignment of CAPA reports (corrective/preventive action requests)

· Gathers information from multiple departments (Customer Service, Product Specialists, Product/Process Owners and Regulatory) in order to assist RA and process owners with the determination of risk related to a reported Nonconformance

· Ensure all nonconforming product(s) are identified and removed from use

· Ensure completion and accuracy of all associated quality records related to nonconformance and CAPA reports

· Assist with the performance and documentation of Internal Audits and support External Audits, as required

· Lead and/or participate in product related team meetings and/or performance reviews, as needed

· Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items)

· Perform computer operations for data entry, and provide tracing/trending reports

· Additional support of routine QA department standard operating procedures (SOPs) is also expected when necessary

How will you get here?

Education

· Bachelor’s degree in Biological Sciences or a related field

Experience

· Three (3) years of experience in a Quality regulated environment

Knowledge, Skills, Abilities

· Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications

· Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing

· Tracking and trending tools and reporting techniques

Ability to:

· Provide accurate QS tracking and trending reports

· Exercise independent discretion and judgment in execution of duties

· Plan and organize oneself in a consistent manner

· Be a self-starter with the ability to positively motivate others in a cooperative fashion

· Establish and maintain effective working relationships with other staff members

· Effectively communicate both orally and in writing to management, customers and regulatory personnel

· Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry

Preferred Qualifications:

· Background in diagnostics

· Experience in Quality Systems and investigations

· Good procedural writing skills

At Thermo Fisher Scientific, each one of our 65,000 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.

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.