Quality Specialist II

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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.

• 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.

• 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.

• 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.

• Travel…