Quality Control Scientist

Integrated Resources, Inc.; Fremont (CA); On-site; USD 55,000 - 75,000; Full time

Job summary

Integrated Resources, Inc. in Fremont, CA is seeking an Engineer/Scientist I to perform testing of intermediate and raw materials in a QC laboratory setting. You will manage sample receipt, data generation and product verification under cGMP/GMP guidelines, and document results.

The role requires strong laboratory skills, attention to safety, and the ability to work independently while supporting data analysis and SOP updates. Excellent documentation and communication are essential for success.

Qualifications

• Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.

Responsibilities

• Conducts analytical and functional testing of raw materials and intermediates according to approved SOPs as part of QC Raw Material testing.
• 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 simple revisions and updates to QCs SOPs and/or worksheets as necessary, and initiate procedure change orders.
• Summarize test data, maintain lot histories and evaluate data for trends and discrepancies.
• Performs other responsibilities to support the needs of the department as assigned by Supervisor.

Skills

Pipetting

Safety

Hazardous chemical handling

cGMP understanding

Reading comprehension

Follow directions

Documentation writing

Verbal communication

Word processing

Spreadsheets

Data analysis

Concentrations and dilutions

Education

BS/BA in Chemistry, Biochemistry, or Bioscience

Tools

Excel

Job description

Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Engineer/Scientist I will perform testing of intermediate and raw materials. 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 other QC lab supporting activities.

Responsibilities

• Conducts analytical and functional testing of raw materials and intermediates according to approved SOPs as part of QC Raw Material testing.
• 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 simple revisions and updates to QCs SOPs and/or worksheets as necessary, and initiate procedure change orders.
• Summarize test data, maintain lot histories and evaluate data for trends and discrepancies.
• Performs other responsibilities to support the needs of the department as assigned by Supervisor.

Qualifications

• Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.

Required Skills

• Strong laboratory skills including pipetting, safety, 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.
• 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.