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Quality Control Chemist

Monobind
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Job Title: Quality Control Chemist I

Salary Range: $40,000 – $55,000 per year

 

Position Summary: The Quality Control Chemist I is an essential member of Monobind’s Quality team, responsible for performing testing and quality evaluations on finished immunoassay components and products to ensure they meet rigorous performance, stability, and regulatory standards. This role focuses on executing QC testing for ELISA and CLIA products, analyzing data, and supporting the release of high-quality diagnostic kits while maintaining strict compliance with cGMP and ISO requirements. This entry-to-mid level role is well-suited for a detail-oriented, analytical individual with laboratory experience in immunoassays who is committed to quality and regulatory compliance. The Quality Control Chemist I plays a key role in ensuring the reliability and safety of Monobind’s diagnostic products.

 

Essential Duties and Responsibilities:

 

  • Performing Quality Control (QC) testing on finished immunoassay components including trend analysis, stability testing, and final kit release on ELISA and CLIA products.
  • Evaluating new quality control samples for all immunoassay products including internally manufactured and externally sourced controls.
  • Operating laboratory equipment such as pipettes, microplate washers, microplate mixers, microplate readers, and automated immunoassay analyzers.
  • Analyzing, recording, and reporting quality control data with a high level of accuracy and attention to detail.
  • Identifying and promptly reporting any test failures, out-of-specification results, or anomalous data to the QC Supervisor and management
  • Performing all tasks in accordance with cGMP and ISO standards
  • Collaborating with the QC, Production, and R&D teams to continuously improve product quality and support Monobind’s reputation for excellence.

Qualifications:

  • High School Diploma with at least 2 years of relevant experience or Associate’s Degree in Chemistry or other science-related field.
  • Working knowledge of cGLP, cGMP, Quality Systems with FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 13485 a plus
  • Laboratory skills, including basic record keeping, familiarity with Enzyme Immunoassay’s (ELISA, CLIA), pipetting, and analytical testing
  • Possess excellent record keeping skills and writing capacity for technical reports
  • Ability to carry out instructions furnished in written, oral, or diagram form
  • Strong communication (verbal and written) and interpersonal skills
  • Ability to balance workloads and multiple issues at once.
  • Excellent computer skills with experience with MS Office, Excel, and Word with the ability to quickly learn to use new software and Monobind’s internal software.
  • Ability to demonstrate a sense of urgency and attention to detail in approach to day-to-day work, as well as ability to work independently or with others
  • Possess a positive attitude and the ability to influence others

 

 

About Monobind:

Monobind Inc. is a private company headquartered in Lake Forest, CA. It is a global leader in diagnostic development and innovation since 1978. Monobind manufactures 60+ analytes immunoassay kits in ELISA and CLIA formats and semi-to-fully automated instruments, as well as clinical controls. All products are CE Marked and Monobind is FDA Registered and ISO 13485 Certified.