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Description
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?
As part of the MAS QC team, and the overall Quality Control department the QC Engineer/Scientist I will be an integral part of the MAS QC team to test and evaluate MAS products before release. Our facility in Fremont, CA is part of the Clinical Diagnostics Division where our aspiration is to aspire to be our customers' most trusted partner, by providing innovative diagnostic solutions that improve patient outcomes. MAS QC products deliver accurate results to help ensure reliable patient results with multiple products that encompass general chemistry, immunoassays, cardiac, toxicology, urinalysis, and specialty areas. We'd love you to join our team!
Using standard operating procedures (SOP) and good manufacturing practices (GMP), the QC Engineer/Scientist I will perform intermediate and final release testing of filled components and finished goods kits. The Engineer/Scientist I will be responsible for all aspects of laboratory testing, such as sample receipt, data generation, product verification, data analysis and summarization, instrument operation, and all other QC lab supporting activities.
What will you do?
- Conducts analytical and functional testing of intermediates, finished goods kits and/or filled bottle reagents/calibrators according to approved SOPs.
- Perform testing using chemistry clinical analyzers and document test results accurately using Excel spreadsheets and workbooks.
- Documents test results, complete batch records, document problems and other relevant information under cGMPs.
- Perform revisions and updates to QCs SOPs and/or worksheets as necessary, and manage changes throughout the change control process.
- Summarize test data, maintain lot histories and evaluate data for trends and excursions.
- Performs other responsibilities to support the needs of the department as assigned by Supervisor.
- Participate in PPI, Lean, and 5S programs, as required.
- Completed additional duties as required
How will you get here?
Education
- Minimum BS/BA in Chemistry, Biochemistry, or Bioscience
Experience
- 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry
Knowledge, Skills, and Abilities
- Strong laboratory skills including pipetting, safety, handing of Biohazardous material, and hazardous chemical handling.
- Understanding of cGMP and how it applies to the work environment is preferred.
- High level of reading comprehension skills.
- Ability to follow written and verbal directions with a high level of accuracy.
- Must be able to write clear, understandable documentation.
- High level of verbal communication skills.
- Manual dexterity, must be able to lift/move up to 20 pounds.
- Intermediate word processing and spreadsheet software skills.
- Ability to manage multiple tasks simultaneously.
- Ability to work independently.
- Ability to perform simple data analysis and to summarize results.
- Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.
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.
Compensation and Benefits
The salary range estimated for this position based in California is $60,000.00-$80,000.00.
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
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