Full Time

QC Automation Sr Specialist

Posted 1 month ago
Application ends: November 3, 2021
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Job Description

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

  • Support development, implementation, management, and business administration of QC automation project related quality systems (i.e. E-logbook, smart QC, etc.) and related processes to ensure adherence to regulatory/guideline and BeiGene requirements
  • Assist in developing and maintaining Standard Operating Procedures (SOPs) for QC automation related quality systems (i.e. E-logbook, smart QC, etc.)
  • Support testing and training activities as needed for implementation and/or enhancements of QC automation related quality systems
  • 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 as assigned
  • Support all necessary aspects of QC automation project and operations as assigned
  • Participate in testing and verification of new and revised system functionality/enhancements.
  • Work cross-functionally to support the creation and revision of policies and procedures in support of QC automation project and operations
  • Consult with management and business process owners to ensure of QC automation related quality systems are aligned with user requirements.

Other duties as assigned

Competencies

Qualification Required:

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

Other Qualifications

  • Experience with a Lab automation quality System (smart QC 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
  • Fluency in both English and Mandarin Chinese preferred

Travel

  • As required

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