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! Send your resume to hr@quantimetrix.com.