Specialist, Quality Assurance - Records Management
539
**
8+ years pharmaceutical or regulated industry experience
Bachelor's degree in life sciences or engineering
Experience with aws s3, sharepoint, and file shares
**
The job posting is for a Specialist in Quality Assurance focused on Records Management within a pharmaceutical company, requiring extensive experience in managing electronic records and compliance with regulatory standards. The role emphasizes collaboration, data integrity, and effective communication with various stakeholders in a hybrid work environment.
**
Job Summary
This role is responsible for the archival and lifecycle management of electronic records within the Records Management Center of Excellence.
The specialist must perform annual reviews and clean-up of archived data across repositories like AWS S3 and SharePoint to ensure compliance.
Candidates are expected to support audit requests and deliver information retrieval within agreed service-level targets.
Matching Summary
Match Score: 75
**
The job posting is for a Specialist in Quality Assurance focused on Records Management within a pharmaceutical company, requiring extensive experience in managing electronic records and compliance with regulatory standards. The role emphasizes collaboration, data integrity, and effective communication with various stakeholders in a hybrid work environment.
**
Skills & Requirements
Must-have
8+ years pharmaceutical or regulated industry experience
Bachelor's degree in Life Sciences or Engineering
Experience with AWS S3, SharePoint, and file shares
Knowledge of GDP and computer systems validation
Ability to follow SOPs and change control processes
Nice-to-have
Experience with Veeva, ECM, or Kneat-eVal platforms
Familiarity with FDA, ICH, SOX, and GDPR regulations
Multi-language communication skills
Ability to work in ambiguity and make rapid decisions
Experience supporting regulatory audits
Key Requirements
Minimum 8 years experience in pharmaceutical or regulated industry
Bachelor's Degree in Life Sciences, Engineering, or related discipline
Experience with document control management under Good Documentation Practices