15 Apr
Data Integrity Project Analyst Contingent Role
California, Dublin , 94568 Dublin USA

Vacancy expired!

Software Guidance & Assistance, Inc., (SGA), is searching for a Data Integrity Project Analyst Contingent Role for a Contract assignment with one of our premier Pharmaceutical clients in Dublin, CA. Responsibilities :

  • 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.
  • 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.
Required Skills:
  • 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.
Preferred Skills:
  • 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
SGA is a Certified Women's Business Enterprise (WBE) celebrating over thirty years of service to our national client base for both permanent placement and consulting opportunities. For consulting positions, we offer a variety of benefit options including but not limited to health & dental insurance, paid vacation, timely payment via direct deposit. SGA accepts transfers of H1 sponsorship for most contracting roles. We are unable to sponsor for Right-to-Hire, Fulltime, or Government roles. All parties authorized to work in the US are encouraged to apply for all roles. Only those authorized to work for government entities will be considered for government roles. Please inquire about our referral program if you would like to submit a candidate for any of our open or future job opportunities. SGA is an EEO employer. We encourage Veterans to apply. To view all of our available job postings and/or to learn more about SGA please visit us online at www.sgainc.com .

Vacancy expired!

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