Quality Assurance & Documentation Specialist II

BioNano; San Diego (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

BioNano in San Diego seeks a Quality Specialist II to support the QMS under ISO 13485, including batch record review, incoming inspection, and document control to ensure product quality and regulatory compliance.

The role drives identification of quality system gaps, resolves documentation discrepancies, and contributes to continuous improvement with cross-functional teams. Strong attention to detail and collaborative skills are essential in our growing biotech environment.

Qualifications

• Experience with document control and change control processes.
• Knowledge of ISO 13485, GDP, and IVD/IVDR regulations is required.
• Strong organization and detail orientation with procedure adherence.
• Able to coordinate cross-functional quality activities and audits.
• Proficient in MS Office and document management systems.

Responsibilities

• Document and Change Control owner: create, revise, route, review, approve, and release documents.
• Review receiving material specs and manufacturing batch records for accuracy and compliance.
• Maintain quality and manufacturing records, organize and retain per procedures.
• Manage controlled numbers for quality system documents and records.
• Support onboarding and training by coordinating training assignments and records.
• Prepare and issue Certificates of Analysis (CoAs) per specs and procedures.
• Identify quality system gaps and drive process improvement with other departments.

Skills

Document control

Change control

Manufacturing batch records

Material specifications

Quality record management

ISO 13485 knowledge

GDP

IVD/IVDR regulations

Attention to detail

Cross-functional collaboration

MS Office proficiency

Education

Bachelor's degree in Biology, Chemistry, Biomedical Engineering, or related field

3+ years in a GMP-regulated environment

Experience in Quality Assurance/Quality Systems/Document Control in biotech/diagnostics/medical devices

Experience supporting QA activities for life science platforms or diagnostic systems

Tools

MS Office

Job description

BioNano in San Diego seeks a Quality Specialist II to support the QMS under ISO 13485, including batch record review, incoming inspection, and document control to ensure product quality and regulatory compliance.

The role drives identification of quality system gaps, resolves documentation discrepancies, and contributes to continuous improvement with cross-functional teams. Strong attention to detail and collaborative skills are essential in our growing biotech environment.