QA Documentation Control Specialist - On-Site Irvine

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

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.