Engineer II QA

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture dedicated to working the right way for the right reasons with the customer always top of mind. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fastgrowing global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career.

Location/DivisionSpecificInformation

This role is based at our Fremont CA site supporting our Niche Diagnostics Business Unit within the Clinical Diagnostics Division. The facility is an ISO 13485 certified and FDA 21 CFR 820 compliant organization. We design and manufacture in vitro diagnostic reagents/products for use in clinical and research applications in the areas of toxicology therapeutic drug monitoring and quality controls.

Work Schedule

Standard (MonFri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office

Discover Impactful Work:

The Engineer II QA will play an important role in driving compliance improvements to ensure we are meeting regulatory requirements around our Safety Data Sheets and controlled substances program by collaborating with the R&D and Operations teams to achieve the highest level of quality standards. This will involve analyzing highly technical information to ensure formulations are reported accurately into critical systems (i.e. WERCs) and ensure controlled substances are identified and compliance is maintained.

A day in the Life:

• Collaborate with the R&D and Technical Operations teams on documenting and reviewing highly technical product formulation data to ensure accurate SDS creation.
• Collaborate with the R&D Technical Operations and Regulatory Affairs teams on documenting and reviewing highly technical product formulation data to ensure controlled substance compliance.
• Work multifunctionally with other teams to create or revise documentation via the established document control process.
• Work multifunctionally with R&D Regulatory Affairs Product Legislation Compliance and Labelling to discuss chemical hazards ensure accuracy and regulatory compliance
• Identify Controlled Substances located in Thermo Fisher Scientific products calculate the full composition and compose summary sheets for DEA Exemption submissions
• Provide technical support and guidance on chemical safety issues related to IVDR integration
• Review and analyze QC data from instruments such as chemical analyzers for incoming material inspections to ensure compliance with established specifications and standards for GMP
• Conduct regular Gemba walks following Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) to observe and analyze processes identify areas for improvement and engage with frontline employees to enhance operational efficiency and quality
• Review and recommend revisions or changes in scope format and content to existing documentation. Maintain records and files of work and revisions.
• Work closely with Quality Assurance to ensure documentation implemented is aligned with regulatory requirements.
• Maintain strict compliance with Quality Management System requirements ISO 13485 cGMP QSR and other regulations and/or standards.
• May be called upon the implement procedural changes supporting continuous improvement initiatives.
• Respond to Quality action related to CAPAs SCARs or nonconformances.
• Organize large amounts of technical information applying Advanced MS Word and Excel functions as well as manage many technical documents simultaneously.
• Ability to work independently and collaborate with multifunctional teams to identify appropriate content updates as required.
• Participate in multifunctional documentation projects as required.
• Keep functional leadership and/or project management appraised project status.

Keys to Success:

Education

• B.S./B.A. in a scientific subject area (e.g. chemistry chemical engineering biology bioengineering etc. required.

Experience

• 2 years experience in a regulated environment (ISO 13485 FDA QSRs GMP or IVDs).
• Thorough understanding of software programs such as WERCS Studio QAD Oracle PLM and MasterControl.

Knowledge Skills Abilities

• Analytical and qualitative skills
• Excellent interpersonal planning and time leadership skills
• Able to work independently with minimal direction
• Able to implement 8D or similar approach for Corrective Actions
• Able to implement new programs and processes with little direction
• Proficient with Microsoft Office Suite (Excel Word etc.
• Passionate about Quality and process improvement

This position does not offer relocation benefits.

Excellent Benefits Package

• Review our companysTotal Rewards
• Medical Dental & Vision benefitseffective Day 1
• Paid Time Off & Holidays
• 401K Company Match up to 6
• Tuition Reimbursement eligible after 90 days!
• Employee Referral Bonus
• Employee Discount Program
• Recognition Program
• Charitable Gift Matching
• Company Paid Parental Leave
• Career Advancement Opportunities

Compensation and Benefits

For more information on our benefits please visit: