Quality Control Scientist I — GMP Raw Materials Testing

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

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.