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Job ID :
41175BR
Location :
US - California - Canoga Park
:
Job Description

The Engineer/Scientist II, QC will perform routine QC testing of various product lines in accordance with standard operating procedures and final product inspection to ensure all specified criteria are met.

Key Responsibilities:

• Ensure completion and accuracy of product and lab related quality control records
• Maintain applicable testing logs, filing of quality control records, and maintenance of record retention as required by company documentation policy
• Perform routine QC functions such as equipment calibrations, managing lab supplies and test materials, and maintain a clean and orderly laboratory area
• Perform product evaluation tests or special test requests to assist product technical teams with process improvements, corrective and preventative actions
• Create and maintain database of critical product performance measures for trend analysis
• Maintain database of Key Performance Indicator metrics for QC laboratory
• Process and coordinate testing and disposition of product returns
• Generate nonconformance report of product failure and notify appropriate parties
• Participate in team meetings to troubleshoot product performance and/or process issue
• Assist with assay troubleshooting and laboratory investigations of Out of Specification results
• Assist with new analytical method validations and method transfer into the QC laboratory
• Assist with stability testing
• Assist with writing method validation or stability protocols and reports
• Review and approve QC test data
• Plan and implement training course for QC Associates in product line testing and various QC departmental functions
• Assist in the collaboration and editing of QC department test protocols
• Serve as a primary QC representative on new product transfer into the QC department
• Coordinate and assign the QC daily workload
• Assist with other QC department functions as needed
Minimum Qualifications:

• Bachelor degree in a biological or related science from an accredited college or university plus two (2) years of laboratory experience; OR Master’s degree in a biological science from an accredited college or university and a minimum of one (1) year of laboratory experience
• MS Office computer skills required for record and analysis reporting – i.e. Word, Excel, etc.
• Knowledge of Basic Good Laboratory Practices (GLP) and GMP requirements

Ability to:

• Exercise independent discretion and judgment in execution of duties
• Be a self-starter with the ability to positively contribute to process improve in all areas of QC
• Strong organizational and analytical skills and ability to train other employees
• Plan and execute tasks in a consistent and timely manner to meet product release deadlines
• Establish and maintain effective working relationships with other staff members
• Effectively communicate both orally and in writing
• Perform computer operations for data entry and reporting
• Demonstrate ability to work well in a team environment and independently as needed
• Familiar with basic statistical concepts and software applications

Preferred Qualifications:

• General knowledge of Serological and Molecular HLA typing protocols




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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