Quality Assurance & Document Control Specialist

Nucleus Biologics; San Diego (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

Nucleus Biologics, The Cell Performance Company, is a leading provider of cell-growth media and related technologies. The Quality Specialist supports QA and document control within the Quality Management System, reporting to the Senior Manager of Quality.

The role ensures controlled documents, batch records, and audit readiness in a fast-paced cGMP setting across functions. The ideal candidate has 2–4 years in QA/document control, strong regulatory knowledge, and experience with eQMS (ZenQMS

Qualifications

• 2-4 years of experience in quality assurance and/or document control within a cGMP pharmaceutical, biotechnology, or medical device environment.
• Working knowledge of GMP, ISO, and FDA regulatory requirements.
• Experience with electronic quality management systems (eQMS); hands-on experience with ZenQMS highly desired.

Responsibilities

• Maintain controlled documents and quality records within the QMS.
• Issue manufacturing records, batch records, and labeling to support production and release activities.
• Coordinate change requests for controlled documentation.
• Support audits (internal, customer, and regulatory) and audit readiness.
• Enter and maintain quality data in the eQMS and generate routine reports.

Skills

Quality assurance

Document control

GMP knowledge

Regulatory compliance

Communication skills

Education

Bachelor’s degree in scientific discipline or related field

High school diploma

Tools

ZenQMS

eQMS software

Job description

Nucleus Biologics, The Cell Performance Company, is a leading provider of cell-growth media and related technologies. The Quality Specialist supports QA and document control within the Quality Management System, reporting to the Senior Manager of Quality.

The role ensures controlled documents, batch records, and audit readiness in a fast-paced cGMP setting across functions. The ideal candidate has 2–4 years in QA/document control, strong regulatory knowledge, and experience with eQMS (ZenQMS