Position Summary

The Chemist I, Bioanalytics performs quality control testing of raw materials, in-process, and final products, following general instructions on routine work and detailed instructions on new assignments.

Essential Functions (ES) and Responsibilities

• Perform quality control chemistry and/or Immunoassays (ELISA) and enzymatic activity test methods for raw materials, in-process, and final products according to approved Standard Operating Procedures (SOP’s).

• Perform instrument maintenance, calibration or qualification according to written procedures.

• Perform testing as needed to generate data for method validations and other special projects, following general instructions on routine work and detailed instructions on new assignments.

• Fulfill requests from management for assistance in other matters as needed.

• Accountable for following Standard Operating Procedures (SOP’s) and adhering to cGMP guidelines.

• Utilize cGMP practices in documentation and execution of job functions.

• Review documentation on trained tasks as assigned by manager.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

• Education Requirements: B.S. in Chemistry, Biochemistry, Molecular Biology, or related science discipline.

• Experience Requirements: This position requires 0-3 years of experience in a laboratory setting.
• Preferred Education Requirements: B.S. in Chemistry, Biochemistry, Molecular Biology, or related science discipline. 

Preferred Experience

• Familiarity with chemical and biochemical testing is desired.
• Good communication skills, detailed oriented and able to work well with others are necessary qualities.
• The individual should be flexible and be able to handle multiple priorities.
• Able to use personal computer for data entry.
• Perform math calculations involving dilutions, fractions, decimals, and percentages.
• Understand and follow instructions, record information, find solutions to practical problems or request assistance.
• Work in a regulated environment (FDA, EPA, etc.) preferred but not required.

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.

Core Competencies/Behaviors:

Exercises judgment within defined procedures to determine appropriate action to routine problems. Prioritization of work with direction of QC Management.