BioLegend’s Quality Assurance Coordinator is responsible for supporting 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 under direct supervision. This role requires strong 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 in a support capacity 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.
- Responsible for personal daily task management, training plans and performance management.
- Generates, reviews 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).
- Assists with various forms of customer support (ex. Inquiry responses, customer surveys, declarations of conformity).
- Assists with data preparation for Quality Management Reviews.
- Provides administrative support for external audits (regulatory or customer).
- 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.
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
- Bachelor’s degree in scientific discipline or equivalent experience.
- 1+ years Quality Management System (QMS) experience working in a regulated Good Manufacturing Process (GMP) environment
Preferred Qualifications – Education and Experience
- 1-2 years experience in IVD, including ISO 13485:2016 and MDSAP.
Condition of Employment
Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, BioLegend requires proof of COVID vaccination for all U.S.-based employees (subject to limited exceptions) beginning January 18, 2022
Diversity is foundational to PerkinElmer and we know that hiring talent with different backgrounds will provide a greater impact for our customers and a more inclusive workplace for our team. Our commitment to creating a culturally diverse workplace is REAL! We know that it’s the people that make PerkinElmer a wonderful, enriching place to work that is why we are always searching for talented and motivated individuals to join the PerkinElmer Family.
So what’s in it for you?
CAREER DEVELOPMENT
We create a customized development plan to help you achieve your career goals. We partner with you to build a long and rewarding career by providing:
- On-the-job training
- Mentoring relationships
- Ongoing career development planning
- Company and external training programs
- Opportunities for internal career mobility
COLLABORATIVE CULTURE
Our company fosters innovation, knowledge sharing, and teamwork for long-term success. We are committed to the development of your career, giving you opportunities to learn and grow. Simply put, we make a difference for you, so you can make a difference in the world.
GLOBAL IMPACT
We are passionate about our work and the benefits we create for our customers, our communities, and our environment. Every day, we help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.
Learn About Our Corporate Capabilities
Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.
With about 13,000 employees worldwide, we pioneer scientific technologies for food and drug safety, environmental monitoring, industrial analysis, screening and diagnostic testing, and imaging for life sciences. We provide better detection, imaging, and informatics to help our customers make a profound impact on the world.
