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!
Job Summary
The Quality Assurance associate manager oversees personnel engaged in applicable Quality Assurance processes which may include non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing and validation. This role requires strong leadership skills, attention to detail, the ability to communicate and a willingness to adapt to changing business needs.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Responsibilities may include some or all of the following:
- Acts as the primary Quality Assurance contact for critical QMS processes such as non-conformances, complaint management and tracking and CAPA.
- Reviews quality records such as final product release batch records.
- Provides guidance to product development for new product release processes, stage gate reviews and design history files.
- Supervises QA personnel, including daily task management, training plans and performance management.
- Generates, reviews, approves and maintains QMS documents.
- Responsible for monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
- Provides data for and participates in Quality Management Reviews.
- Supports supplier quality and validation activities.
- Participates in the eQMS selection and implementation.
- Other responsibilities as needed.
iACT Competencies
- innovate – Be better, keep improving, be more efficient, creative, and be in the forefront of development
- Aspire – Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
- Collaborate – Foster teamwork, common goals, selflessness, communication and mutual support
- Transform – Adapt, learn, re-invent and change for future development and growth
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
- 5 years experience in IVD,
Work Environment & Physical Demands
Office
While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.