We are seeking a Quality Assurance Specialist to join our team and support our quality systems processes including Internal Audits, CAPAs, Document Control and Supplier Quality. As a Quality Assurance Specialist, you have excellent technical writing skills. You are able to communicate professionally at all levels, and have demonstrated leadership and organizational skills. You have high ethical standards and trustworthiness. You are able to analyze data and information. You have the ability to function under deadline and provide high quality deliverables. This position is based at our Fargo, ND location.
About the Role:
As a Quality Assurance Specialist, you will be responsible for maintaining quality assurance standards, processes and controls. You will develop and implement methods for inspection, testing, sampling, and training. You will support Aldevron's internal audit program to ensure processes are performed in accordance with written procedures and other applicable external requirements and appropriately and adequately identifying and prioritizing internal risks through the internal audit process and ensure deficiencies are addressed. You will support of the qualification and monitoring of Aldevron's suppliers/vendors. You will also support the CAPA system by ensuring that all events are investigated, actions are put into place, and records are closed within a timely manner.
- At least one year of Quality Assurance or Regulatory Compliance experience within a field subject to regulatory compliance (preferred)
- Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels
- Experience with the FDA's GMP and GLP Guidelines as well as ISO experience. Ideally, candidate will have knowledge of FDA's phase I guidelines and GMPs related to production of molecular diagnostic controls.
- Ability to work on cross functional teams
- Very organized