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Engineer/Scientist III, QC

Pharmaceutical Product Development (PPD)

Fremont, California, United States of America

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Fremont, CA / Clinical Diagnostics Division

How will you make an impact?

This position will perform various laboratory operation tasks such as; sample receipt, data generation, product verification, data analysis and summarization, out-of-specification investigations, raw material qualifications, and other QC lab supporting activities. Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Engineer/Scientist III, QC will perform routine and non-routine testing of incoming and manufactured raw materials. Regularly provides mentorship and training to junior QC Engineer/Scientists.

What will you do?

  • Conduct analytical and functional testing of raw materials according to approved SOPs. 
  • Act independently to determine methods and procedures when performing new assignments.
  • Perform testing using chemistry clinical analyzers and document accurate test results using spreadsheets and workbooks. Review and interpret data against trend charts, in order to evaluate product performance.
  • Perform initial solving of issues which arise during routine analysis, and perform out of specification investigations. If needed, initiate non-conformance reports, CAPAs, deviations or variances.
  • Lead improvements projects within area, and participate in PPI and 5S programs to drive continuous improvements.
  • Work multi-functionally to resolve product issues, maintain timelines, and ensure product quality.
  • Review and approve documentation completed by other QC Engineer/Scientists.
  • Perform revisions and updates to SOPs and initiate document change orders. 
  • Participate in interdepartmental and team meetings to support new product development, validations, and sustaining projects. 
  • Perform other responsibilities to support the needs of the department as assigned by the Supervisor. 

How will you get there?

Education

  • Minimum BS/BA in Chemistry, Biochemistry, Bioscience or related degree

Experience

  • 5+ years of Assurance/Quality Control experience, preferably in the medical diagnostics industry

Knowledge, Skills, and Abilities

  • Strong laboratory skills including pipetting, safety, and hazardous chemical handling. 
  • Effective leadership skills to informally lead teams, and influence others.
  • Understanding of cGMP and how it applies to the work environment.
  • Ability to write clear, understandable documentation.
  • Ability to follow written and verbal directions with a high level of accuracy. 
  • Strong verbal communication skills. 
  • Intermediate word processing and spreadsheet software skills. 
  • Ability to manage multiple tasks simultaneously. 
  • Ability to work independently.
  • Ability to perform data analysis, interpret and summarize results. 
  • Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The salary range estimated for this position based in California is $90,900.00–$136,350.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Job posted: 2024-04-05

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