Specialist, Quality Assurance - Records Management

Merck & Co., Inc.

Rahway, NJ, USA
Not specified; not specified; not specified
**
8+ years pharmaceutical or regulated industry experience
Aws s3, sharepoint, and file share repository management
Gdp document control and computer systems validation
** Merck & Co., Inc. is seeking a Specialist in Quality Assurance for Records Management to oversee the archival and lifecycle management of electronic records. The role is hybrid and requires a minimum of 8 years of experience in the pharmaceutical industry or a regulated field, focusing on data integrity, compliance, and effective communication with stakeholders. **

Job Summary

  • The Records Management e-Data Specialist ensures the accuracy, integrity, and compliance of archived electronic data across multiple repositories.
  • This role requires supporting business partners with timely data retrieval requests and assisting with internal and external audit activities.
  • Candidates must possess a Bachelor's Degree and at least eight years of experience within the pharmaceutical or a similar regulated environment.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking a Specialist in Quality Assurance for Records Management to oversee the archival and lifecycle management of electronic records. The role is hybrid and requires a minimum of 8 years of experience in the pharmaceutical industry or a regulated field, focusing on data integrity, compliance, and effective communication with stakeholders. **

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 8+ years pharmaceutical or regulated industry experience
  • AWS S3, SharePoint, and file share repository management
  • GDP document control and computer systems validation
  • Power BI reporting and data analytics capabilities
  • Access control administration and audit support

Nice-to-have

  • Experience with Veeva, ECM, or Kneat-eVal platforms
  • Familiarity with FDA, ICH, SOX, and GDPR regulations
  • Ability to work in ambiguity and make rapid decisions
  • Multi-language communication skills preferred
  • Track record of continuous process improvement

Key Requirements

  • Bachelor's Degree in Life Sciences, Engineering, or related discipline
  • Minimum 8+ years of experience in pharmaceutical or regulated industry
  • Valid work authorization for the United States (implied by location)

Work Rights

Not specified

Tailored Resume

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