Vendor Outsourcing QC Associate I

2 weeks ago

Foster City, United States Hydrogen Group Full time

Job Description:

A leading Biopharma company are actively seeking a motivated candidate to fill their Vendor Outsourcing QC Associate I opportunity. This is an initial 12-month contract role with opportunity to extend an extra 6-months. This is a hybrid role; 3-days on site, 2-days remote based in Foster City, CA. Salary ranges between $35-40/hour depending on experience.


The candidate will be responsible for conducting functional internal audits on behalf of Vendor Outsourcing, and for assisting in business process improvement initiatives to maximize quality and efficiencies. The candidate should have a deep understanding of vendor outsourcing’s responsibilities throughout the vendor sourcing, contracting, as well as an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics etc.


Requirements:

  • B.Sc./ B.A. and 5+ years of relevant experience in the pharmaceutical or biopharma industry.
  • PMP certification or equivalent certification.
  • Project management experience in Pharmaceutical or Healthcare industries
  • Demonstrates a thorough knowledge of Good Clinical Practice “GCP”, Good Pharmacovigilance Practices “GVP”, Good Laboratory Practice “GLP”, Good Documentation Practice “GDP” and ICH E6 R2 compliance requirements.
  • Thorough understanding of current global and regional trends in compliance.


Daily activities will include, but are not limited to:

  • Working within a team environment and leading functional internal audits of VO’s electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO’s documentations.
  • Adherence to work procedures, compliance standards, and the preservation of data integrity.
  • The role also involves coaching VO team members to resolve issues from a QC standpoint and serving as a primary reviewer of QC data for inspection readiness.

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