Manufacturing Quality Systems Specialist

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 Document Control Specialist provides comprehensive support to the Manufacturing Department, ensuring compliance with cGMP standards through meticulous administrative and technical document control. This role involves writing, reviewing, and revising Standard Operating Procedures (SOPs), batch records, corrective and preventive actions (CAPAs), planned and unplanned deviations, and conducting departmental audits. Additionally, the Document Control Specialist supports manufacturing by assisting with routine and troubleshooting laboratory experiments. The ideal candidate thrives in a fast-paced environment, demonstrates strong multitasking abilities, and approaches challenges with a positive “can-do” attitude.

What You’ll Do

• Author, review, and revise Standard Operating Procedures (SOPs), batch records, and other controlled documents to meet Manufacturing Department’s cGMP and regulatory requirements.
• Conduct internal departmental audits to ensure compliance with regulatory and company standards.
• Support root cause analysis and assist in developing preventive measures to ensure long-term compliance.
• Participate in continuous improvement initiatives by optimizing documentation processes and enhancing operational efficiency.
• Train and guide manufacturing personnel and document control systems, SOPs, and regulatory requirements.
• Assist with troubleshooting complex manufacturing and routine laboratory processes to resolve technical challenges as well as meet manufacturing demand.
• Support the Manufacturing Department by conducting feasibility experiments to support Quality Validation protocols.
• Support the department in inventory management.
• Act as a liaison between the quality and manufacturing departments to ensure alignment and effective communication.

What We’re Looking For

• 2+ years of experience in document control, quality assurance, or manufacturing in a cGMP-regulated environment.
• Strong knowledge of cGMP, FDA regulations, and quality management systems.
• Excellent organizational, analytical, and problem-solving skills.
• Ability to manage multiple priorities.
• Knowledge of working with ERP systems (e.g., SAP, IQMS) is preferred.
• Strong knowledge of Microsoft Word, Excel, PowerPoint.
• Routine computer entry, word processing, spreadsheets and graphics.

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 $30 - $35 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!