Specialist, Quality Assurance - Records Management

29

Rahway, NJ, USA
Hybrid
Bachelor's degree in life sciences or engineering
8+ years pharmaceutical or regulated industry experience
Experience with aws s3, sharepoint, and file shares
The job posting is for a Specialist in Quality Assurance focused on Records Management at Merck, located in Rahway, NJ. The role involves managing electronic records, ensuring compliance, and supporting data retrieval within a hybrid work environment

Job Summary

  • This role ensures the accuracy, integrity, and compliance of electronic archived records across multiple repositories including AWS S3 and SharePoint.
  • The specialist is responsible for performing annual reviews, clean-ups, and maintaining access controls to support business partners and audit requests.
  • Candidates must possess strong communication skills to collaborate with global functions and drive continuous improvements in operational processes.

Matching Summary

Match Score: 85

The job posting is for a Specialist in Quality Assurance focused on Records Management at Merck, located in Rahway, NJ. The role involves managing electronic records, ensuring compliance, and supporting data retrieval within a hybrid work environment.

Skills & Requirements

Must-have

  • Bachelor's Degree in Life Sciences or Engineering
  • 8+ years pharmaceutical or regulated industry experience
  • Experience with AWS S3, SharePoint, and file shares
  • Knowledge of GDP and cGMP compliance standards
  • Proficiency in Power BI, Excel, and reporting tools

Nice-to-have

  • Experience with Veeva, ECM, or Kneat-eVal systems
  • Familiarity with FDA, ICH, SOX, and GDPR regulations
  • Ability to work effectively in ambiguous environments
  • Multi-language communication capabilities
  • Experience supporting external regulatory audits

Key Requirements

  • Bachelor's degree required
  • Minimum 8 years of relevant experience
  • Pharmaceutical or regulated industry background mandatory

Work Rights

Not specified

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