The Quality Assurance Specialist will perform and administer Quality Assurance (QA) activities at BioLegend, in accordance with BioLegend Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of BioLegend’s Quality Management System (QMS). This position will be an integral part of the Quality Assurance team and will be responsible for documenting and processing non-conformances, corrective actions, customer complaints as well as performing product release.
- Create, review, and approve QMS documentation in the company.
- Assure products (current and new), materials and process, including their applicable documentation, are compliant with applicable QMS requirements.
- Work with internal department heads to ensure implementation of uniform quality practices and share/train best practices.
- Work with management to ensure that the principles of quality and compliance are included in the company’s culture.
- Support change control activities.
- Support the QMS training program, including ISO13485, and regulatory requirements, and act as a resource to ensure quality compliance.
- Support non-conforming activities, corrective and preventive action, root cause analysis, process improvement and complete resolution towards customer requests, customer feedback, inspections, audits, deviations and other related issues.
- Perform batch records review and product release
- Conduct internal audits and investigations.
- Support, hosts, and leads, customer, supplier and regulatory audits, including timely document search and delivery during audits, as necessary.
- Responsible for creation of reports for QA, including detailed analysis.
- Perform other duties as assigned
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Quality of work
Minimum Qualifications – Education and Experience
- Minimum Education (or substitute experience) required: BA /BS in Biology or related field or equivalent
- Three years of experience with quality assurance procedures under cGMP, ISO 9001, or ISO 13485 standards.
- Thorough working knowledge of QMS documentation requirements.
- Excellent data management and analytical skills and ability to multi-task. Strong communication skills – written, verbal and computer
- Experience conducting QA audits
- Knowledge of ISO 13485, and cGMP, and regulations.
- Flexible team player in dynamic environment
- Experience with MS Word, Excel, Power point, Visio; Adobe Acrobat; ERP systems
- Previous experience with an electronic document control system
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?
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
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.
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.
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.