Quality Systems & Change Control Specialist II

BioNano Genomics; San Diego (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

BioNano Genomics is seeking a Quality Specialist II to support the implementation and maintenance of the QMS in accordance with ISO 13485 and applicable regulatory requirements. The role includes batch record reviews, incoming inspections, document control, and identifying gaps for continuous quality improvement.

Success in this role requires meticulous attention to detail, strong cross-functional collaboration, and the ability to drive quality initiatives within a growing biotechnology

Qualifications

• Experience in document control, change control, batch records, material specifications, and quality records management.
• Working knowledge of ISO 13485 quality management system requirements, GDP and IVD/IVDR regulations.
• Strong organizational skills with attention to documentation discrepancies and procedures.
• Ability to multi-task and adapt to changing priorities.
• Proven communication skills and ability to coordinate with cross-functional teams.
• Proficiency in MS Office software applications.

Responsibilities

• Document and Change Control owner: create, revise, route, review, approve, and release documents.
• Coordinate change assessments and ensure timely implementation per procedures.
• Review receiving materials specs and manufacturing batch records for accuracy and compliance.
• Manage quality and manufacturing records, organize and retain per procedures.
• Assign and track controlled numbers for quality documents and records.
• Support employee onboarding and training documentation.

Skills

Document control

Change control

Batch records

Material specifications

Quality records management

GDP

ISO 13485

IVD/IVDR regulations

Cross-functional collaboration

Attention to detail

Education

Bachelor's in Biology/ Chemistry/ Biomedical Eng or related

Tools

MS Office

Job description

BioNano Genomics is seeking a Quality Specialist II to support the implementation and maintenance of the QMS in accordance with ISO 13485 and applicable regulatory requirements. The role includes batch record reviews, incoming inspections, document control, and identifying gaps for continuous quality improvement.

Success in this role requires meticulous attention to detail, strong cross-functional collaboration, and the ability to drive quality initiatives within a growing biotechnology