Project Coordinator #JN -042021-62568

Dublin, California
Industry: Helpdesk / Tech Support / Field Technician
Job Number: JN -042021-62568

Description:

  • The Data Integrity Project Analyst, with minimal supervision, manages cross-functional, complex projects utilizing PMI methodology This position is responsible for the management, coordination, implementation, and control of local Data Integrity projects, while ensuring alignment with the strategy, priorities, and goals of the site.
  • This role must interact and influence at all levels of the organization while aligning with stakeholders, driving change, and mitigating risks and resource constraints. Projects range across manufacturing, quality, systems, and business processes.

 Key Duties and Responsibilities: % of Time or Importance

  • 50%: Successfully lead cross-functional teams in Data Integrity project execution including aligning with stakeholders, defining project scope / objectives, tracking deliverables, resolving key issues and achieving desired outcomes.
  • 30%: Provide technical expertise for investigation and resolution of addressing Data Integrity gaps.
  • 20%: Teams with and guides project teams to ensure high quality and regulatory compliant solutions. Provides Data Integrity knowledge to support addressing site Data Integrity gaps.

 Job Qualifications:

  • Bachelor’s degree or equivalent work experience required
  • Minimum of 3 years of project management experience preferably in a regulated manufacturing environment
  • Minimum of 3 years of quality systems experience in FDA regulated medical device / pharmaceutical manufacturing environment(s)
  • Demonstrated knowledge and experience with Data Integrity Principles in a Medical Device or Pharmaceutical environment.

 Desired Skills, Experience, and Competencies:

  • Demonstrated knowledge and application of Project Management skills and PMI standards; PMI or Six Sigma Black Belt certification is a plus.
  • Experience in managing projects involving systems integration with an understanding of Software Quality Assurance and Validation Principles
  • Demonstrated ability to manage cross-functional project teams to a desired outcome
  • Ability to manage multiple projects and priorities by organizing workload efficiently
  • Excellent communication (written, verbal, and presentation) skills
  • Exhibits diplomacy while establishing and maintaining cooperative working relationships with employees at all levels of the organization
  • Demonstrated user level knowledge of GXP systems
  • Excellent problem solving, time-management, and task prioritization skills
  • Demonstrated ability to lead effective change management
  • High computer literacy including MS Office and Data Visualization
  • A positive and professional attitude as well as a strong work ethic


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