Job Description:
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 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.
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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.
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Core Competencies/Behaviors:
Exercises judgment within defined procedures to determine appropriate action to routine problems. Prioritization of work with direction of QC Management.
Physical Requirements:
- Exposure to infectious material (human source products), toxic chemicals, chemical fumes and odors, electrical hazards, temperature extremes when going to and from coolers and freezers. Stressors: Long or unusual work hours may be required for quality control testing during manufacturing of immunotherapy products.
- Physical Demands: Sits at desk or bench 15–20% of the time and operates a personal computer using sign and finger dexterity. Sits at laboratory bench 70-75% of the time testing samples. 10% of the time lifting, carrying, pushing, pulling chemicals, samples, and supplies weighing no more than 30 lbs.
