Quality 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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Specialist II

Summary

The Quality Specialist will support the implementation and maintenance of Bionano's Quality Management System (QMS) in accordance with ISO 13485 and applicable customer and regulatory requirements. This role is responsible for key Quality Assurance activities, including batch record review, incoming inspection, and document control, to ensure product quality and compliance with established specifications. The role also supports the identification of quality system gaps, resolution of documentation discrepancies, and continuous improvement of quality processes. Success in this role requires strong attention to detail, effective cross-functional collaboration, and the ability to support continuous improvement within a growing organization.

Primary Duties and Responsibilities

• Document and Change Control (25%) - Serve as the process owner for document and change control activities, including document creation, revision, routing, review, approval, and release. Facilitate change control review meetings as needed to support timely evaluation and implementation of changes. Coordinate change assessments, ensure required reviews and approvals are completed, and verify that changes are implemented in accordance with established procedures.
• Receiving Material Specifications and Manufacturing Batch Records (25%) - Review and approve receiving material specifications and manufacturing batch records to ensure accuracy, completeness, and compliance with established quality system requirements.
• Quality and Manufacturing Records Management (20%) - Maintain quality and manufacturing records, ensuring proper organization, storage, retrieval, and retention in accordance with applicable procedures and recordkeeping requirements. Identify documentation gaps and discrepancies and coordinate their timely resolution with the appropriate departments.
• Quality-Controlled Number Management (10%) - Assign, track, and maintain controlled identification numbers for quality system documents, records, and other applicable materials in accordance with established procedures.
• Employee Onboarding and Training Support (10%) - Support employee onboarding by coordinating required training assignments, maintaining training records, and assisting with training documentation.
• Certificate of Analysis (5%) - Prepare and issue Certificates of Analysis ( CoAs ) in accordance with approved specifications, procedures, and applicable quality requirements.
• Other Duties (5%) - Perform additional duties and responsibilities as assigned to support Quality operations and organizational objectives. Support the identification of quality system gaps and opportunities for process improvement, including coordination with relevant departments to address identified issues.

Required Skills and Abilities

• Demonstrated experience in document control, change control, manufacturing batch records, material specifications, and quality record management.
• Working knowledge of ISO 13485 quality management system requirements, Good Documentation Practices (GDP) and IVD/IVDR regulations .
• Strong organizational skills, attention to detail, and the ability to identify documentation discrepancies and follow established procedures.
• Ability to multi-task; flexible and adaptable to changing priorities.
• Proven people, verbal, and communication skills. Demonstrate ability to negotiate assigned tasks with other departments.
• Ability to coordinate cross-functional quality activities, communicate identified discrepancies, and elevate unresolved quality issues through established channels.
• Proficiency in MS Office software applications.

Education, Certifications, Licenses

• Bachelor's degree in Biology , Chemistry, Biomedical Engineering, or a related scientific or technical discipline preferred; equivalent relevant education and experience may be considered.
• At least 3 years of experience working in a GMP-regulated environment is required.
• Experience in Quality Assurance, Quality Systems, Document Control, or a related function within a biotech, diagnostics, medical device, or regulated manufacturing environment is preferred.
• Experience supporting quality activities for complex life science platforms, diagnostic systems, or assay-based products is preferred.

Leadership Responsibility (Direct/ Indirect): N/A

Additional Requirements

• Travel Requirements:
• Less than 5% travel time expected.
• Physical Requirements and Work Environment:
• Sit and stand for prolonged periods
• Repeating motions that may include the hands, wrists and/or fingers
• Use of hands to finger, handle, or feel, and reach with hands and arms
• Stand and/or move about the office or in various environments (including tight and confined spaces), or from one worksite to another
• Specific visual abilities, including close vision and ability to adjust focus, read, review, and assess the accuracy and thoroughness of the work assigned
• Verbal abilities require communicating with others to exchange information
• Occasionally adjusting or moving objects up to 30 pounds in all directions
• Work environment involving low/high temperatures; hazardous conditions, low ventilation, noisy environments, small/enclosed spaces
• In-person interaction with others indoors and outdoors
• Use standard computer, telephone and related equipment for communication, and recordkeeping

Disclaimer

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This description generally reflects management’s assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice .