Sr. Specialist/Manager, LIMS Business Administrator
San Mateo, CA

Job Description

Qualifications:

Education Required:

* Bachelor's degree in science or combination of education and equivalent work experience
* Experience with a Lab Information Management System (LabVantage, Sample Manager, LabWare, StarLIMS or similar
* Understanding of Quality best practices, including familiarity with Quality Systems Regulations, GxPs, and applicable ISO Standards
* Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs
* Excellent attention to details
* Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment
* Effective oral and written communication skills
* Experienced working cross-department with Quality, IT, Clinical, Regulatory and Development
* Working knowledge of business process and process improvement
* Experienced interfacing with external software vendors

Essential Functions of the job:

* Support development, implementation, management, and business administration of the Laboratory Information Management System (LIMS) and related processes to ensure adherence to regulatory and BeiGene requirements
* Assist in developing and maintaining Standard Operating Procedures (SOPs) for LIMS
* Support testing and training activities as needed for LIMS implementation and/or enhancements
* Manage and maintain LIMS static data such as user matrix, specifications, analysis, stability protocols, data tables and instruments
* Gather user requirements and work with technical lab personnel to define the appropriate configuration for IT to meet defined business requirements
* Provide system oversite activities including audit trail reviews, system reviews, resolution of problem reports, data maintenance as applicable
* Author protocols and technical documents and provide summary reports from LIMS
* Support all necessary aspects of LIMS projects and operations as assigned
* Fluency in Mandarin Chinese is a plus
* Other duties as assigned

Supervisory Responsibilities:

* May manage Quality staff and provide coaching, and support development plans

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

Computer Skills:

* PC literate with MS Office skills, including Smartsheet, Teams, PowerPoint, Outlook, Word, Excel, Visio

Travel:

* As required

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