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Thermo Fisher Scientific · 3 days ago
QA Engineer II
San Francisco, CA
Full-time
Onsite
Mid Level
$72K/yr - $108K/yr
2+ years exp
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Responsibilities
Collaborate across functions, demonstrating quality and manufacturing expertise to address problems, interpret data, and determine next steps.
Support implementation of secondary suppliers and assist with the development of raw material specifications.
Participate in change control activities for documents and manufacturing processes.
Ensure accurate use of quality systems and processes.
Provide mentorship and direction to ensure ISO/Quality system compliance.
Spearhead maintenance, completeness, and accuracy of Quality records.
Lead problem requests (nonconformance's), complaint records, and corrective and preventive actions (CAPAs).
Build, review, and revise quality policies and procedures, and perform trainings when needed.
Review batch records in accordance with cGMP, including good documentation practices (GDP).
Ensure traceability to materials and equipment.
Generate Certificate of Analysis for finished good materials.
Identify and record any deviations related to a product's release; help process, and review deviations as needed.
Complete product release steps in our business systems.
Supports internal and external audits, including audit of batch records and release activities for cell therapy products.
Write, review, and revise Standard Operating Procedures (SOPs).
Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners.
Support Vendor Qualifications. Identify and implement improvements using quality data, metrics, and Practical Process Improvement (PPI) tools.
Qualification
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Required
Bachelor’s degree in science or engineering, or related field is preferred. Equivalent education and experience can be substituted.
2+ years of relevant Quality/Manufacturing/Engineering or related experience.
Previous experience in a cGMP environment.
Previous experience in Cell Therapy is preferred.
Proven track record to collaborate in multi-functional teams.
Demonstrated ability to conduct quality investigations including root cause analysis.
Strong verbal and written communication skills in English.
Solid understanding of cGMP practices.
Knowledge of regulatory guidelines: EU, US, ICH, etc.
Change control, Deviation and investigations, root cause analysis and risk assessment.
Preferred
Experience With SAP, TrackWise, LIMS, EDMS Is Preferred.
Effective written, interpersonal, and presentation skills.
Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and ability to learn new software programs.
Benefits
Healthcare
Annual Incentive Plan Bonus Scheme
Company Pension/Retirement
Employee Benefits
Comprehensive Total Rewards Package
National Medical and Dental Plans
National Vision Plan
Health Incentive Programs
Employee Assistance and Family Support Programs
Commuter Benefits
Tuition Reimbursement
Paid Time Off (PTO)
Paid Holidays
Paid Parental Leave
Accident and Life Insurance
Short- and Long-Term Disability
Retirement and Savings Programs
401(k) U.S. Retirement Savings Plan
Employees’ Stock Purchase Plan (ESPP)
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10,001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (173)
2022 (314)
2021 (349)
2020 (251)
Funding
Current Stage
Public CompanyTotal Funding
$11.05BKey Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B
Leadership Team
Daniella Cramp
Senior Vice President and President
Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
Recent News
2024-05-26
Company data provided by crunchbase
