The Quality Assurance Specialist will perform and administer Quality Assurance (QA) activities at BioLegend in accordance with Biolegend’s 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 QMS documentation, working closely with other departments to provide training regarding best practices, supporting new product validations, and supporting the QMS training program as a whole.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Create, review, and approve QMS documentation for the company and be responsible for document management and filing
Assure products (current and new), materials and processes, including their applicable documentation, are complaint with applicable QMS requirements
Work with internal department heads to ensure implementation of uniform quality practices, share/train best practices, and work with management to ensure that the principles of quality and compliance are included in the company's culture
Support change control, Engineering control, new product and validations (equipment, methods, and processes), and risk management
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 actions, root cause analyses, and process improvements
Complete resolutions towards customer requests, customer feedback, inspections, audits, deviations and other related issues
Conduct internal audits and investigations
Support, host, and lead, customer, supplier, and regulatory audits, including timely document search and delivery during audits, as necessary
Support supplier performance and evaluation
Support Management Review with metrics data on Quality processes
Create reports for QA, including detailed analyses
Other duties as required
Competencies
Accountability
Dependability
Quality of work
Teamwork
Minimum Qualifications - Education and Experience
Bachelor’s Degree in Biology or a related field
3 years of experience with quality assurance procedures under cGMP, ISO9001, or ISO 13485 standards
Thorough working knowledge of QMS documentation requirements
Excellent data management and analytical skills and the ability to multi-task
Strong communication skills (written, verbal, and computer)
Experience conducting QA audits
Knowledge of ISO 13485, and cGMP, and regulations
Proficiency with Microsoft Word, Excel, PowerPoint, Visio, Adobe Acrobat
Previous experience working with an Enterprise Resource Planning (ERP) system
Preferred Qualifications – Education and Experience
Previous experience working with an electronic document control system
MDSAP implementation experience preferred
About BioLegend
BioLegend develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support.
Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. BioLegend's reagents are supported by superior customer service and a quality management system that is certified for ISO 13485:2003. Our aggressive product development program, through technology licensing, collaborations, and internal hybridoma development, produces strategic reagents for use in a variety of applications including:
Flow cytometry and mass cytometry
ELISA and ELISPOT
Immunoprecipitation and ChIP
Western blotting
Immunofluorescence microscopy
Immunohistochemistry
In vitro or in vivo functional assays.
Quantitative Multiplexing
BioLegend offers the broadest selection of fluorochrome conjugates for multi-color flow cytometry. With an experienced biochemistry team, BioLegend is well position...ed to offer a wide range of custom conjugation services to meet our customers' specific needs.
Our commitment to the research community is reflected in generous sponsorships of societies and meetings world-wide, our monthly travel award for junior investigators, and excellent bulk pricing. With iPhone/iPad apps, web tools, beautifully detailed posters, and new reagents, we look forward to bringing more creative innovation to make your research legendary.
