Document Control Specialist

Beigene, Ltd. Emeryville , CA 94608

Posted 2 months ago

BeiGene, Ltd. is a commercial-stage biopharmaceutical company rooted in China that is dedicated to becoming a global leader in the discovery, development and commercialization of innovative, molecularly targeted and immuno-oncology drugs for the treatment of cancer.

The Document Control Specialist is responsible for managing GxP controlled documents through the development process while adhering to strict timelines, maintaining version control, and managing reviewers and approvers.

Essential Functions of the job:

  • Manage and maintain controlled documents in Veeva Vault QualityDocs (VVQD) including creating draft documents, maintaining profile card metadata, and linking supporting documents

  • Track Document Change Requests and Document Change Controls within to ensure reviews and approval are completed within strict timelines

  • Coordinate the review, approval, and archival of BeiGene's controlled documents in accordance with GxP regulations

  • Edit and proofread controlled documents for formatting, legibility, completeness, and adherence to Quality templates and procedures

  • Implement and utilize advanced word processing and automation features of Microsoft Office software

  • Build and Run reports in Veeva Vault QualityDocs to ensure accuracy and completeness of the document control process

  • Participate in validation testing for system implementations and updates

  • Manage Document Control email inbox with prompt responses to internal customers

  • Other duties as assigned

Competencies:

Ethics

  • Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.

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 and 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 within budget.

Computer Skills:

Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, etc.) Veeva vault, Compliancewire

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Document Control Specialist

Beigene, Ltd.