Quality Assurance

Alameda, CA, US • Posted 6 hours ago • Updated 6 hours ago
Contract Corp To Corp
Contract Independent
Contract W2
12 Months
No Travel Required
Able to Sponsor
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Quality Assurance
  • GxP
  • CSV
  • Veeva Vault

Summary

Position: Quality Assurance

Location: Alameda, CA (Onsite)

Duration: 12+ Months (with possible extension)

Job description:

As a Quality Assurance, you would be involve in overseeing GxP compliance, managing health authority inspections, and aligning quality systems for oncology drug development.

Key Responsibilities

  • Computer Software Assurance/Validation (CSV/CSA): Author, review, and execute validation deliverables including User Requirements Specifications (URS), Functional Specifications (FS), Configuration Specifications (DS), and IQ/OQ/PQ test scripts.
  • Quality Systems Design: Assess current states, identify gaps, and implement improvements across Clinical and commercial QA standards.
  • Compliance & Metrics: Track and trend metric data, review deviations, and manage Corrective and Preventive Actions (CAPAs).
  • Process Optimization: Translate complex quality processes (CAPA, Deviations, Change Control, Audits) into functional system requirements and risk-based testing strategies.
  • Inspection Readiness: Prepare for and support health authority inspections (such as from the FDA), mock audits, and vendor evaluations.
  • Client Advisory: Act as a trusted advisor to quality leaders during workshops, proof-of-concepts, and end-to-end system rollouts.
  • Cross-Functional Partnership: Collaborate with Clinical Operations, Regulatory Affairs, and Translational Medicine to provide compliance guidance.

Core Requirements

  • Experience: Generally requires 5–8+ years of related experience in GxP quality assurance or compliance within the biotech/pharmaceutical industry.
  • Regulatory Knowledge: Deep familiarity with GxP regulations.
  • Technical Skills: Experience in validating Veeva Vault system
  • Skills: Strong problem-solving, document authorship, and stakeholder-influencing capabilities.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: RTX18f0cc
  • Position Id: 9100783
  • Posted 6 hours ago
Contact the job poster
Vikas Sharma

Vikas Sharma

IT Recruiter @ Spotline
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