Job Description

Company Overview

Quantimetrix, located in Redondo Beach, California, is a company that designs, develops, and manufactures clinical laboratory quality controls. For nearly 50 years, we have delivered industry-leading products and services to the medical community.

The ideal candidate serves as a key contributor in the formulation, development, and continuous improvement of complex in-vitro diagnostic (IVD) products. This individual independently manages high-priority projects, collaborates with cross-functional teams, and drives operational excellence by optimizing laboratory practices and ensuring compliance with GMP and regulatory standards.

What You’ll Do

• Identify formulation gaps, inefficiencies, or cost-saving opportunities and present improvement proposals to leadership.
• Participate or lead daily formulation schedules to ensure batch readiness and timely completion of production
• Perform Routine Manufacturing Transaction in ERP system
• Review and approve completed batch records for accuracy, completeness, and regulatory compliance before submission to QA.
• Supports internal walkthroughs and mock audits in the formulation area to identify and resolve compliance gaps proactively.
• Independently prepare reagent and buffer formulations for manufacturing use
• Troubleshoot formulation deviations, equipment issues, and raw material concerns
• Review and revise Quality records such as batch records and formulation SOPs
• Coordinate with QC, Production, and Warehouse teams to ensure accurate staging and usage of materials
• Support validation, scale-up, and continuous improvement activities within manufacturing
• Assist with raw material qualification, in-process checks, and formulation-related CAPAs or Non conformance
• Support inventory Management for the department
• Ensure all formulation activities align with GMP, ISO 13485, and internal procedures

What We’re Looking For

• Strong knowledge of GMP and ISO 13485 standards

• Experience with bulk solution preparation, reagents, and buffer systems

• Proven ability to troubleshoot complex formulation and process issues

• Experience working with ERP systems and batch record documentation

• Strong organizational skills and ability to manage multiple priorities independently

• Excellent communication and cross-functional collaboration skills

Why Join Us

• Work on impactful products that support the medical and clinical laboratory community

• Collaborative team environment with opportunities for growth and development

• Play a key role in improving processes, quality, and operational excellence

Compensation

The hourly range for this position is $25 - $30 an hour and will be determined based on experience, skills, education, certifications, and location

Benefits

• Medical, dental and vision benefits
• Life insurance
• 401K match
• FSA
• PTO
• Educational assistance program
• Employee Discounts provided through PEO
• Employee Assistance Program

Apply now and help us bring our products to patients worldwide!

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