BioLegend is looking for an Quality Management Systems Administrator to support our Quality System software platform as we are expanding our Quality Assurance team to accommodate some exciting changes to our organization such as product development of regulated devices, implementation of GMP, and a move to our specious new campus!
In this role, you will use your technical acumen with Electronic Quality Management systems such as PLM and ERP and work with outside computer system vendors, BioLegend’s existing IT department, and our Quality and Validation team to coordinate implementation activities and handle management of system access and permission. You will also assist with Quality and Validation Configuration management the management of user training.
The eQMS Administrator will be responsible for the implementation of system updates, configuration changes, creating reports and handling support issues, and working with technical and functional teams to solicit needs, determine feasibility, and implement configuration changes.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Daily administration and support of the Quality Software System including managing user setup, roles and security, customization of objects, fields, record types, and page layouts.
Monitor interfaces to integrated systems ensuring that all systems are operating as designed.
Participates in the software testing process, which includes test plans, contributing to test cases, appropriate testing environments and coordinating and executing testing
Maintain current knowledge of the Quality System Software’s features and functionality, providing recommendations for improvements
Implement configuration changes and customizations as required by the business
Oversee changes and provide clear and timely communication as necessary with releases
Serve as an escalation point for Quality System Software related support issues from Business Units team, which provide second level support
Identifies and resolves conflicting requirements
Responsible for changes to baseline requirements through effective application of change control processes, tools, and appropriate escalation
Documents complex system workflows and business processes
Identify ways to assist management in product and/or business planning and improvement through requirements development and analysis. Propose new product features and updates.
Determine, document and communicate the impact of proposed system enhancements and changes to current business processes
Perform other duties as assigned
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
2 years of recent experience in an eQMS administrative role for a large user base (250+ users)
Bachelor’s degree or equivalent work experience
2 years of experience with PLM systems i.e. Pilgrim Smart Solve, Agile/ Oracle, Veeva, Master Control
Proficient with initial roll out and module phase additions
Proficient with creating modifiable PDFs and forms and process flow analysis and creation
Understanding of industry regulated requirements for validation, change control, ECO, training, and quality system interface for CAPA, internal audit, nonconformance, and complaint handling
Preferred Qualifications – Education and Experience
Familiarity with MDSAP, 21 part 11 compliance and quality records maintenance
Experience on in vitro medical diagnostic devices, preferred
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.