Lab QC Analyst

$52,000 - $52,000/Yr

Tekberry - Union City, CA

Full-time - Mid Level

Union City, CA

Professional, Scientific, and Technical Services

About the position

The Lab QC Analyst position at Tekberry involves conducting routine and non-routine analyses of raw materials, in-process materials, and finished products in a laboratory setting. The role is essential for ensuring quality control and compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). The analyst will be responsible for calibrating lab equipment, compiling data, and participating in investigations related to product quality. This position offers an opportunity to work with a leading company in the veterinary medicine and vaccination industry.

Responsibilities

• Conduct routine and non-routine analysis of raw materials, in-process materials, and finished products according to established procedures.
• Compile data for documentation of test procedures including stability program testing.
• Calibrate and maintain lab and analytical equipment.
• Participate in preparation of failure and complaint investigations, summaries, and reports of abnormalities.
• Revise and update standard operating procedures as needed.
• Perform special projects on analytical and instrument problem solving and develop testing and analysis methods in accordance with established guidelines.
• Test finished products for precision and performance.
• Analyze test results and prepare test batch records.
• Process and analyze data using basic statistical methods and internal software.
• Analyze in-line testing rotor lot data for lot release and issuing performance results.
• Support the company's retention program, ensuring well-organized storage of samples.
• Initiate, perform, and monitor stability studies and programs in compliance with applicable regulations.
• Test and release incoming raw materials (enzymes and reagents).
• Initiate and assist in resolving non-conformance related to QC inspection.
• Test, analyze, and submit Proficiency Survey samples (CAP and API).
• Maintain equipment and lab supplies inventory.
• Support troubleshooting and assigned projects.
• Review instrument production logs, analyze, and report abnormalities.
• Maintain current knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Requirements

• Bachelor of Science in Chemistry, Biochemistry, Biology, or any other relevant scientific discipline.
• 2+ years of quality control and analytical laboratory experience.
• Experience with in-vitro diagnostics preferred.
• Laboratory and technical competence including basic statistical analysis.
• Working knowledge of Microsoft Word, PowerPoint, Excel, and Outlook.
• Strong attention to detail and numbers.
• Effective written and communication skills.

Benefits

• Health insurance
• Dental insurance
• Vision insurance