BioLegend | About Us
At BioLegend, we are committed to providing researchers with the most comprehensive and cutting-edge high-quality reagents for life science research. Being part of Revvity, a global provider of health science solutions, technologies, expertise and services for life sciences and diagnostics, allows us to extend the mission of enabling our customers to do legendary discovery. Join us and make a difference!
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Acts as the primary Quality Assurance contact for critical QMS processes such as non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing and validation.
- Reviews quality records for all related areas of responsibility.
- Supervises QA personnel, including daily task management, training plans and performance management.
- Serve as qualified quality auditor for internal and supplier audits.
- Generates, reviews, approves and maintains QMS documents.
- Provides various forms of customer support (ex. Inquiry responses, customer surveys, declarations of conformity).
- Provides data for and participates in Quality Management Reviews.
- Participates in external audits (regulatory or customer) as a QMS subject matter expert and for administrative support.
- Participates in the use of the eQMS system and expanded applications as appropriate.
- This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
- Other responsibilities as needed.
- Other projects or responsibilities as may be required.
Minimum Qualifications – Education and Experience
- Bachelors degree in scientific discipline or equivalent experience. 3 years QMS experience working in a regulated, GMP environment
Preferred Qualifications – Education and Experience
- 3 years experience in IVD, including ISO 13485:2016 and MDSAP.