Quality Scientist III

    Thermo Fisher Scientific Inc.
    Fremont, CA 94536
    Full-time
    Similar jobs pay $14.55 - $23.66
    Refer friends, get paid!

    Job Description

    Thermo Fisher is at the forefront of the global response to COVID-19. We are working with governments, agencies, industry partners and researchers globally to ensure priority access to instruments, consumables, safety supplies and other products to address the outbreak. This key role will play a valuable part in our efforts.

    Do you have a passion for innovative ideas and groundbreaking discoveries? Now is an exciting time to join our Genetic Sciences business. With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you'll help solve some of the world's toughest challenges. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond. Quality Scientist III
    Job Description
    Quality Scientist III
    Req ID 135990BR
    When you're a 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.
    The primary role of this position is targeted toward clinical studies support and study site management. In this role the primary responsibilities include:

    Position Summary:
    • This candidate will work closely with cross functional teams to write, edit, review and finalize technical and quality documents to support commercial and new products. The individual will write or process, and implement all quality documents related to commercial product activities related product issues, including procedure change orders and document change orders to reflect approved changes. Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented.
    Key Responsibilities:
    • Write and provide guidance in quality documentation for commercial and new products
    • Technically strong to work independently with manufacturing/QC R&D and various scientists to transfer information into quality documents like NCAR, CAPA and SCAR documentation.
    • Designs and writes a new layout for SOPs relating to Manufacturing production/process instructions, policies, and procedures
    • Lead cross functional documentation and other projects as required
    • Support Senior Scientists in corrective and preventive actions for technical issues to ensure timely and accurate documentation of root cause analysis
    • Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance
    Minimum Requirements/Qualifications:
    • BS/MS in a scientific discipline with 5-10 years diagnostic industry experience
    • Familiarity with SAP/ ERP system.
    • Familiarity with Design Control
    • Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
    • Knowledge of ISO 13485, FDA QSRs and GMP
    • Proofreading and editing skills, and an aptitude for numbers and detail oriented work requiring a high degree of accuracy.
    • Proactive in suggesting improvements in workflow.
    • Must have excellent customer service and listening skills.
    • Able to sit, stand and/or use keyboard for long periods of time.
    • Must have the skills to work as a strong contributor in a team effort.
    • Demonstrate good flexibility with changes to working environment and deliver high quality results in a high-pressured deadline oriented environment
    • Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets.
    • Experience in IVD Manufacturing
    • Familiarity with Statistical Process Controls (SPC), Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma)
    • Familiarity in investigating technical issues and writing CAPAs, SCARS, NCARS, out of specification root cause analysis documents
    Non-Negotiable Hiring Criteria:
    Bachelor's degree or equivalent work experience
    This position has not been approved for Relocation Assistance.
    Job Description
    Position Summary:
    • This candidate will work closely with cross functional teams to write, edit, review and finalize technical and quality documents to support commercial and new products. The individual will write or process, and implement all quality documents related to commercial product activities related product issues, including procedure change orders and document change orders to reflect approved changes. Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented.
    Key Responsibilities:
    • Write and provide guidance in quality documentation for commercial and new products
    • Technically strong to work independently with manufacturing/QC R&D and various scientists to transfer information into quality documents like NCAR, CAPA and SCAR documentation.
    • Designs and writes a new layout for SOPs relating to Manufacturing production/process instructions, policies, and procedures
    • Lead cross functional documentation and other projects as required
    • Support Senior Scientists in corrective and preventive actions for technical issues to ensure timely and accurate documentation of root cause analysis
    • Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance
    Minimum Requirements/Qualifications:
    • BS/MS in a scientific discipline with 5-10 years diagnostic industry experience
    • Familiarity with SAP/ ERP system.
    • Familiarity with Design Control
    • Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
    • Knowledge of ISO 13485, FDA QSRs and GMP
    • Proofreading and editing skills, and an aptitude for numbers and detail oriented work requiring a high degree of accuracy.
    • Proactive in suggesting improvements in workflow.
    • Must have excellent customer service and listening skills.
    • Able to sit, stand and/or use keyboard for long periods of time.
    • Must have the skills to work as a strong contributor in a team effort.
    • Demonstrate good flexibility with changes to working environment and deliver high quality results in a high-pressured deadline oriented environment
    • Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets.
    • Experience in IVD Manufacturing
    • Familiarity with Statistical Process Controls (SPC), Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma)
    • Familiarity in investigating technical issues and writing CAPAs, SCARS, NCARS, out of specification root cause analysis documents
    Non-Negotiable Hiring Criteria:
    Bachelor's degree or equivalent work experience
    This position has not been approved for Relocation Assistance.

    Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

    Posting ID: 588109061Posted: 2020-11-19