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Engineer/Scientist I, QC

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  • Job
    Full-time
    Mid Level
  • Science
    Engineering
  • $58.1K - $87.1K
  • Fremont

Requirements

  • Keys to Success:
  • Education and Experience:
  • BS/BA in Chemistry, Biochemistry, or Bioscience preferred (equivalent combinations of education, training, and relevant work experience may be considered).
  • Experience in Quality Assurance/Quality Control, preferably in the medical diagnostics industry preferred.
  • Strong laboratory skills, including pipetting, safety, and hazardous chemical handling.
  • Understanding of cGMP and its application in the work environment is preferred.
  • High level of reading comprehension and ability to follow written and verbal directions with a high level of accuracy.
  • Excellent written communication skills to produce clear and understandable documentation.
  • Strong verbal communication skills for effective collaboration with team members.
  • Intermediate word processing and spreadsheet software skills.
  • Ability to manage multiple tasks simultaneously and work independently.
  • Proficiency in performing simple data analysis and summarizing results.
  • Basic math skills, including calculation of concentrations and dilutions, and a strong grasp of algebraic concepts.

Responsibilities

  • Perform analytical and functional testing of raw materials, intermediates, finished goods kits, and/or filled bottle reagents/calibrators according to approved standard operating procedures (SOPs).
  • Use chemistry clinical analyzers for product testing, and accurately document test results using Excel spreadsheets and workbooks.
  • Document test results, complete batch records in compliance with current Good Manufacturing Practices (cGMPs).
  • Perform revisions and updates to QC SOPs and/or worksheets as part of our continuous improvement culture and initiate document change orders.
  • Summarize test data, maintain lot histories, and evaluate data for trends and discrepancies.
  • Perform out of specification investigations (OOS), and participate in investigations on nonconforming material. Document investigations using established procedures and processes.
  • Support the needs of the department by performing assigned responsibilities as directed by the Supervisor.
  • Actively participate in PPI, Lean, and 5S programs, when required.

FAQs

What is the main responsibility of a QC Engineer/Scientist I at Thermo Fisher Scientific?

The main responsibility of a QC Engineer/Scientist I at Thermo Fisher Scientific is to perform intermediate and final release testing of raw materials, filled components, and finished goods kits to ensure product safety and effectiveness for customers.

What are the key qualifications needed for this position?

The key qualifications for this position include a BS/BA in Chemistry, Biochemistry, or Bioscience, experience in Quality Assurance/Quality Control, laboratory skills, understanding of cGMP, strong communication skills, ability to manage multiple tasks, and proficiency in data analysis and math skills.

What benefits and compensation can a QC Engineer/Scientist I expect at Thermo Fisher Scientific?

Thermo Fisher Scientific offers competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. The salary range for this position in California is $58,100.00–$87,125.00, with potential for a variable annual bonus. Additionally, benefits include medical, dental, and vision plans, paid time off, retirement savings programs, employee assistance programs, and more.

How can someone with a disability request accommodations during the application process for this position?

Thermo Fisher Scientific is dedicated to providing reasonable accommodations to job seekers with disabilities. If you require assistance or an accommodation due to a disability, please contact us at 1-855-471-2255 and provide your contact information and specific details about your required accommodation. Our team is here to ensure equal opportunity for all candidates.

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD.

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