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 escalate 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

• Work Location: Onsite – San Diego, CA
• 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

The above physical requirements and work environment characteristics generally reflect those of this position but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with qualified disabilities to perform the essential functions of the position, provided that such accommodation does not impose an undue hardship on the Company.

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.