Quality Assurance & Document Control Specialist

nucleus-biologics-careers; San Diego (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Nucleus Biologics, The Cell Performance Company, is seeking a Quality Specialist to support document control and QA within a fast-paced cGMP environment at our San Diego facilities.

The ideal candidate has 2–4 years in quality assurance or document control, knowledge of GMP/ISO/FDA regulations, and experience with eQMS systems (ZenQMS a plus). This role collaborates across functions to ensure product quality and compliance.

Qualifications

• 2-4 years in quality assurance and/or document control in a cGMP or biotech setting.
• Knowledge of GMP, ISO, and FDA regulatory requirements.
• Experience with electronic quality management systems (eQMS); ZenQMS preferred.
• Detail-oriented with strong documentation accuracy and compliance.
• Effective written and oral communication; able to work across functions.

Responsibilities

• Maintain controlled documents and quality records within the QMS.
• Coordinate creation, review, approval, and archival of documents and records.
• Review batch records and support product release activities.
• Support audits and regulatory inspections; compile requested documents.
• Enter quality data into eQMS and generate routine reports and KPIs.

Skills

Quality Assurance

Document Control

cGMP

Audit Support

eQMS

Regulatory Compliance

Education

Bachelor's degree in scientific discipline

High School Diploma

Tools

ZenQMS

Job description

Nucleus Biologics, The Cell Performance Company, is seeking a Quality Specialist to support document control and QA within a fast-paced cGMP environment at our San Diego facilities.

The ideal candidate has 2–4 years in quality assurance or document control, knowledge of GMP/ISO/FDA regulations, and experience with eQMS systems (ZenQMS a plus). This role collaborates across functions to ensure product quality and compliance.