Quality & Document Control Specialist

Nucleus Biologics; San Diego (CA); On-site; USD 60,000 - 85,000; Full time

Job summary

Nucleus Biologics in San Diego, CA is seeking a Quality Specialist to support QA and document control within a cGMP environment. You will manage controlled documents, issue manufacturing and batch records, coordinate change requests, and support audits across functions.

The ideal candidate has 2–4 years in QA/document control, knowledge of GMP/ISO/FDA, and experience with eQMS systems (ZenQMS preferred). Detail-oriented and collaborative, you will help ensure product release readiness and data

Qualifications

• 2–4 years of quality assurance and/or document control in a cGMP environment.
• Working knowledge of GMP, ISO, and FDA regulatory requirements.
• Experience with electronic quality management systems (eQMS).

Responsibilities

• Support document control system: creation, review, approval, distribution, and archival of quality records.
• Review batch records, logs and manufacturing documentation for accuracy and compliance.
• Support audits by retrieving requested documents and maintaining audit readiness.

Skills

Quality assurance

Document control

GMP knowledge

Regulatory awareness

Attention to detail

Education

High school diploma

Bachelor's degree in science or related field

Tools

eQMS (ZenQMS)

Job description

Nucleus Biologics in San Diego, CA is seeking a Quality Specialist to support QA and document control within a cGMP environment. You will manage controlled documents, issue manufacturing and batch records, coordinate change requests, and support audits across functions.

The ideal candidate has 2–4 years in QA/document control, knowledge of GMP/ISO/FDA, and experience with eQMS systems (ZenQMS preferred). Detail-oriented and collaborative, you will help ensure product release readiness and data