Position Summary

The Chemist II, Bioanalytics will perform quality control testing of raw materials, in-process, and final products with minimal supervision, with a concentration in immunoassays. Uses knowledge of corporate policies to resolve routine problems and ensure compliance with procedures.

Essential Functions (ES) and Responsibilities

• Perform quality control testing for raw materials, in-process, and final product samples, according to approved Standard Operating Procedures (SOPs) and cGMP guidelines
• Complete testing documentation and data entry as required for procedures and tests performed
• Apply knowledge of analyzing issues and uses judgment to make decisions
• Knowledge of immunoassays, specifically plate-based assays and ELISAs
• Utilize cGMP practices in documentation and execution of job functions
• Perform instrument calibration or qualification according to written procedures
• Write and revise SOPs and/or participate in validation protocol execution, as needed
• Perform testing, as needed, to generate data for qualification/validation and special projects
• Fulfill requests from management for assistance in other matters, as needed
• Accountable for following SOPs and adhering to cGMP guidelines
• Review documentation on trained tasks as assigned by QC management
• Use technical and scientific knowledge to recommend solutions to problems as directed by QC management
• Mentor junior analysts and provide training as requested on QC assays.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements: Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or related science discipline.

Experience Requirements: At least three years of experience performing chemical/biochemical testing or developing immunoassays. Work in a regulated environment (FDA, EPA, etc.) is highly preferred.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.