Quality & Documentation Specialist, cGMP Biotech

Nucleus-Biologics; San Diego (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Nucleus Biologics invites a detail-oriented Quality Specialist to support QA and document control within our cGMP Quality Management System. Reporting to the Senior Manager of Quality, this role ensures controlled documents, batch records, and training are up to date to support production and release activities.

The ideal candidate has 2–4 years in QA or document control, with experience in GMP/ISO/FDA regulatory requirements and hands-on use of eQMS systems such as ZenQMS.

Qualifications

• 2–4 years of QA and/or document control in a cGMP pharmaceutical, biotechnology, or medical device environment.
• Experience with electronic quality management systems (eQMS).
• Knowledge of GMP, ISO, and FDA regulatory requirements.
• Detail-oriented with strong written and verbal communication.
• Ability to manage multiple tasks in a fast-paced environment.

Responsibilities

• Maintain controlled documents and quality records within the QMS.
• Issue batch records, manufacturing records, and labeling for production.
• Support change requests and document revisions.
• Assist during internal and external audits and inspections.
• Enter quality data into the eQMS and generate reports.
• Track training and document turnaround times.

Skills

Quality assurance

Document control

Regulatory compliance

Attention to detail

Communication skills

Education

Bachelor’s degree in scientific discipline or related field

High school diploma

Tools

ZenQMS

eQMS

Job description

Nucleus Biologics invites a detail-oriented Quality Specialist to support QA and document control within our cGMP Quality Management System. Reporting to the Senior Manager of Quality, this role ensures controlled documents, batch records, and training are up to date to support production and release activities.

The ideal candidate has 2–4 years in QA or document control, with experience in GMP/ISO/FDA regulatory requirements and hands-on use of eQMS systems such as ZenQMS.