Quality Documentation & Compliance Specialist II

Bionano; California; Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

Bionano is seeking a Quality Specialist to support the Quality Management System (QMS) under ISO 13485 and regulatory requirements. You will handle batch record reviews, incoming inspection, and document control to ensure product quality and compliance with specifications.

The role involves identifying quality gaps, resolving documentation discrepancies, and driving continuous improvement. Strong attention to detail and cross‑functional collaboration are essential in our growing biotech

Qualifications

• Experience in document control, change control and batch records.
• Knowledge of ISO 13485, GDP and regulatory requirements.
• Strong organizational skills and attention to detail.
• Ability to coordinate across departments and meet procedures.
• Experience in GMP-regulated environments is preferred.

Responsabilités

• Document and Change Control ownership from creation to release.
• Review receiving material specs and manufacturing batch records.
• Maintain quality and manufacturing records and resolve gaps.
• Manage controlled numbers for quality documents and records.
• Support onboarding and training documentation.
• Prepare Certificates of Analysis per specs and procedures.
• Identify quality system gaps and drive improvements.

Connaissances

Document control

Change control

Manufacturing batch records

Material specifications

Quality record management

Cross-functional collaboration

Attention to detail

MS Office

Good Documentation Practices

Formation

Bachelor's degree in Biology or Chemistry or Biomedical Engineering

Outils

MS Office

ERP systems

Description du poste

Bionano is seeking a Quality Specialist to support the Quality Management System (QMS) under ISO 13485 and regulatory requirements. You will handle batch record reviews, incoming inspection, and document control to ensure product quality and compliance with specifications.

The role involves identifying quality gaps, resolving documentation discrepancies, and driving continuous improvement. Strong attention to detail and cross‑functional collaboration are essential in our growing biotech