Quality Assurance Specialist - Documentation Control

nRichDX; Orange (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

nRichDX, based in Irvine, CA, is seeking a Quality Assurance Specialist – Documentation Control to maintain quality documentation and support GMP processes.

Responsibilities include routing and organizing controlled documents, version control, and collaborating with cross-functional teams on investigations, audits, and change control. The role also covers calibration, label creation, training records, batch reviews, and continuous improvement.

Qualifications

• Demonstrated experience in Quality Assurance and Quality Control within a regulated laboratory, medical device, or biotech environment.
• Knowledge of Quality Management principles, including document control, CAPA processes, and change management.
• Familiarity with GMP and related regulatory or industry standards.
• Experience with Quality Auditing, internal audits, or supporting external inspections and certifications.
• Proficiency with electronic document management systems and standard office productivity tools.
• Strong attention to detail, organizational skills, and ability to manage multiple document workflows and deadlines.
• Effective written and verbal communication skills, with the ability to collaborate across functional teams.
• Bachelor’s degree in a scientific, technical, or quality-related discipline, or equivalent combination of education and relevant experience.
• Experience in medical devices or pharmaceutical field desired.

Responsibilities

• Manage and maintain quality-related documentation, including SOPs, work instructions, forms and records.
• Route controlled documents, organize repositories, ensure version control and proper distribution.
• Collaborate with cross-functional teams to support quality investigations, audits and change control.
• Assist in calibration and maintenance management, finished goods label creation, training records.
• Review batches and support continuous improvement of quality systems and documentation practices.

Skills

Attention to detail

Organizational skills

Communication skills

Cross-functional collaboration

Documentation management

Education

Bachelor’s degree in scientific/technical/quality discipline

Tools

Electronic document management systems

Office productivity tools

Job description

Company Description nRichDX, based in Irvine, CA, is an emerging leader in liquid biopsy sample preparation, focused on delivering significantly higher analyte yield for molecular testing. The company’s platform, introduced in 2018 after extensive technology development beginning in 2016, is a 510K-exempt, highly differentiated, universal sample prep system. It serves the multi-billion-dollar liquid biopsy and precision medicine markets by addressing one of their biggest challenges: inaccurate diagnostic results caused by insufficient target material. By improving workflow, enhancing test sensitivity, and delivering consistent, reliable test outcomes, nRichDX helps customers increase revenue while reducing operational costs and complexity. Team members contribute to advancing precision medicine by supporting innovative sample prep solutions used in NGS, PCR, and other molecular diagnostic tests.

Role Description The Quality Assurance Specialist – Documentation Control is a full-time, on-site role based in Irvine, CA. This role is responsible for managing and maintaining quality-related documentation, including SOPs, work instructions, forms, and records, to ensure compliance with internal quality standards and applicable regulations. Day-to-day activities include routing controlled documents; organizing and maintaining document repositories; and ensuring version control and proper distribution. The specialist collaborates with cross-functional teams to support quality investigations, audits, and change control, and verifies that documentation accurately reflects current processes. Additional responsibilities include calibration and maintenance management, finished goods label creation management, training record management, batch record review, and assisting in continuous improvement of quality systems and documentation practices.

Qualifications

• Demonstrated experience in Quality Assurance and Quality Control within a regulated laboratory, medical device, or biotech environment.
• Knowledge of Quality Management principles, including document control, CAPA processes, and change management.
• Familiarity with Good Manufacturing Practice (GMP) and related regulatory or industry standards.
• Experience with Quality Auditing, internal audits, or supporting external inspections and certifications.
• Proficiency with electronic document management systems and standard office productivity tools.
• Strong attention to detail, organizational skills, and ability to manage multiple document workflows and deadlines.
• Effective written and verbal communication skills, with the ability to collaborate across functional teams.
• Bachelor’s degree in a scientific, technical, or quality-related discipline, or equivalent combination of education and relevant experience.
• Experience in medical devices or pharmaceutical field desired.