BioLegend has an immediate opening for a Quality Assurance Lead to oversee all applicable Quality Assurance processes for our US FDA registered cGMP manufacturing facility. This position will take the lead in ensuring the successful implementation of our MDSAP program. This is an opportunity with exciting career advancement opportunities that will spearhead the alignment of our existing quality system and applicable regulations with BioLegend’s Regulated product development activities.
This position will be responsible for supporting key quality elements such as document control, investigation management, validation, training, nonconformance, complaint management, and CAPA systems. The Quality Assurance lead will also be responsible for reviewing the quality records and final product releases per established quality management system.
Join us in enabling legendary discovery!
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Function as the primary Quality Assurance contact for our cGMP facility and participate in the quality audits for the diagnostics products
Perform review of documentation of current and new products and procedures, including batch record release
Participate and provide Quality Assurance guidance in product development gate reviews and reviews of design history files for new products
Perform training activities for new hires, existing employees, and for procedural changes in compliance with Training procedure
Initiate, review, and implement the change control processes, including document changes (procedures, work instructions, forms, specifications and other related product documents) and process changes
Ensure security, accuracy and compliance to Document Control requirements for all Quality Documents, including formatting, content changes, and processing
Provide metrics data consisting of monthly reports, quarterly status of Quality Objectives, and other Quality Assurance data as needed
Conduct internal quality audits with audit reports and follow up for timely closures
Organize materials for presentations and participate in Management Review
Review supplier qualifications and performance (purchasing and receiving)
Support equipment qualifications and process validations as needed
Manage the CAPA system with thorough records for root cause investigations and effectiveness checks
Work closely with our Customer Service Department to address and track the customer complaints per applicable requirements
Perform Quality Assurance inspections, including daily shipping inspection of new lots of finished goods products (as needed) to ensure bottling was performed correctly and that all documentation was completed as required
Participate in the development of validation plans and reports for production processes and equipment
Accountability - Accepting responsibility that results in anticipation/prevention of problem areas from actions, and problem solving inside and outside the department/organization.
Dependability - Amount of supervision required, punctuality and attendance.
Quality of Work - Setting high standards regarding his/her work and working environment and acting accordingly; developing quality standards, continuously evaluating performance, products, and procedures; actively seeking ways to improve quality.
Teamwork - Working as a productive member of a cohesive group toward a common goal, and contributing to team development and effective team dynamics.
Minimum Qualifications - Education and Experience
Bachelor’s Degree in a scientific discipline or equivalent work experience
3 years of experience in quality assurance and systems maintenance
3 years of experience with Regulated IVD products
Knowledge of standards and regulations that are outlined in MDSAP (i.e. ISO 13485, 21 CFR 820- USA, regulations for Japan, Brazil, Australia, Canada), and other geographies (IVDD, IVDR)
Strong computer skills with Word, Excel, and PowerPoint
Ability to train manufacturing staff on quality system requirements
Excellent organization skills and attention to detail and accuracy
Self-motivated and able to multi-task and work effectively in a fast-paced environment
Must have good communication and interpersonal skills with customer-oriented focus
Must be a fast learner with ability to clarify areas of ambiguity
Preferred Qualifications – Education and Experience
MDSAP compliance experience
Experience with Enterprise Resource Planning (ERP) systems
Experience with Electronic Data Management Systems
Experience with Electronic Document Management Systems
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
In vitro or in vivo functional assays.
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.