The Quality Associate will play a critical role in implementation of the Bionano Genomics Quality Management System (QMS). In this role the incumbent will be responsible for coordinating and facilitating Quality Assurance (QA) standards based on ISO 13485 to ensure Quality Management System, Customer, and Regulatory Requirements are met. This role is responsible for administrative and project based tasks within the Quality Assurance department. Their role is pivotal in the daily functions of the Quality operation within a growing organization and meticulous attention to detail is a key to success in this role. This person is responsible for comparing the results of Quality Control testing or certificates of analysis to the established specification and/or customer requirements. In addition, this person reviews incoming goods and dispositions and labels materials appropriately. They are primarily responsible for the Batch Record Review, Incoming Inspection, and Document Control processes.
Primary Duties and Responsibilities:
- Participates in the implementation, development, management and integration of the Bionano Genomics QMS.
- Run Document Control activities including creation and/or revision of documents, processing, routing and review, and holding Change Control Board meetings as needed.
- Participate in the design, release and implementation of documentation for process control, process improvement, inspection and test.
- Participate in internal and external quality audits.
- Manage and maintain quality records.
- Review of batch production records and analytical records for completeness and release to ensure compliance with cGMPs and Bionano policies and procedures.
- Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations.
- Work with various departments to set up appropriate documentation to improve efficiency and accuracy.
- Ensuring products tested adhere to established specifications and customer requirements for product release.
- Recommending product disposition and updating records associated with products and incoming goods.
- Labeling products and incoming goods with an appropriate status label after product disposition (e.g. Approved, Rejected, etc).
- May be called upon to draft or revise documentation associated with the Incoming QC process, Document Control, or Batch Record Review.
- Scanning, filing, and other document control related tasks.
- Assist with internal Quality audits of internal departments, as necessary.
- Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance.
- May be called upon to assist with the Supplier Qualification program for maintaining supplier documentation.
- Provide guidance and train others on Quality System and Quality Assurance procedures.
- Perform additional tasks, as assigned.
- Two (2) years Document Control experience in a cGMP medical device, biotech or pharmaceutical environment.
- Strong technical writing ability.
- Knowledge of ISO 9001, ISO 13485, QSR (21 CFR Part 820), GLP, GCP, and GMP.
- Strong organizational skills, task oriented, excellent time management skills.
- Ability to multi-task; flexible and adaptable to changing priorities.
- Works well with limited supervision and as part of a team.
- Proven people, verbal, and communication skills. Demonstrate ability to negotiate assigned tasks with other departments.
- Experience with Batch Record Review, Product Disposition and Document Control.
- Experience with Quality Management Software packages (e.g., Mastercontrol, Trackwise, etc.).
- Experience with complex life science systems and assays, including automated sample prep systems.
Education and Experience Requirements:
- Bachelor’s degree in Science, Engineering, or other relevant field, or equivalent combination of education/training/industry experience.
- 2 years of Experience working in a GMP regulated environment with a good understanding of ISO 9001, ISO 13485, IVD/IVDR/MDR regulations, and 21 CFR Part 820 requirements.