Research Analyst (LBA)

CMIC, Inc.; Hoffman Estates (IL); On-site; USD 60,000 - 85,000; Full time

Job summary

CMIC, Inc. in Hoffman Estates, IL is seeking a Bioanalytical Analyst to perform bio-analysis and sample analysis in compliance with GLP, SOPs, and 21 CFR Part 11, under supervision of group leaders and senior analysts.

The role includes independent biosample work and data handling. Responsibilities cover method development, data processing, worksheet preparation, and maintaining study documentation per Good Documentation Practices.

Qualifications

• Bachelors degree or equivalent experience.
• ELISA bsorbance, fluorescence, luminescence.
• Familiarity with GLP and documentation practices.

Responsibilities

• Understand and comply with GLP requirements and SOPs
• Use lab instruments and maintain equipment properly
• Conduct bio-analysis validation and sample analysis
• Perform pre-study method development with minimal supervision
• Prepare worksheets and data tables; generate chromatograms for reports
• Maintain accurate records per Good Documentation Practices

Skills

GLP compliance

Data processing

Laboratory instrumentation

Good Documentation Practices

Education

Bachelor's degree or equivalent experience

Tools

Watson LIMS

Job description

The ideal candidate will be responsible performing lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts.Independently conduct Bio-analysis validation and sample analysis in support of nonclinical and clinical studies.Conduct Pre-Study with minimal supervision.Utilize establish techniques to compile and analyze data.Document work and maintain study documentation and lab records.

Responsibilities

• Understand and comply with GLP requirements and follow Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies.
• Use and properly maintain lab instrument and equipment appropriately for assigned tasks.
• Conduct Bio-analysis validation and sample analysis independently meeting company quality standards.
• Conduct pre-study method development with minimal supervision.
• Prepare worksheets.
• Data processing and table preparation (i.e., QC data and preparation, data integration, raw data printing, preparation of chromatograms for the report, use of Watson LIMS, etc.)
• Maintain accurate records of work and study documentation per Good Documentation Practices as per company SOPs.

Qualifications

• Bachelor's degree or equivalent experience
• ELISA – absorbance, fluorescence, luminescence