What are the responsibilities and job description for the Quality Associate position at Joulé?
Job Title: Quality Associate
Location: Raleigh, NC
Type: Contract
Overview
The Quality Associate, will play a key role in supporting data migration, batch record review, release activities, and building trackers to enhance operational efficiency. The position requires familiarity with Veeva Vault or similar document management systems.
Responsibilities
Location: Raleigh, NC
Type: Contract
Overview
The Quality Associate, will play a key role in supporting data migration, batch record review, release activities, and building trackers to enhance operational efficiency. The position requires familiarity with Veeva Vault or similar document management systems.
Responsibilities
- Lead and manage the migration of quality documents into Veeva Vault, ensuring accuracy and compliance with documentation standards.
- Support the transition of legacy records into Veeva, maintaining traceability and completeness.
- Build and maintain trackers to monitor key performance indicators (KPIs), batch record status, and release metrics.
- Assist in batch record reviews to ensure documentation is complete, compliant, and ready for release.
- Support release activities by coordinating documentation readiness and collaborating with QA team members and cross functional teams.
Requirements
- Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred)
- 3 years of pharmaceutical/biotech working experience in Quality Assurance in an FDA-regulated industry.
- Experience with batch record review, document control, and release processes.
- Familiarity with SAP inventory system.
- Proficient in Microsoft Office tools, and Veeva Quality systems.
- Strong organization and communication skills and technical writing skills.
- Must be self-directed, goal-oriented, and quality conscious.
- Ability to work cross-functionally with QA, MSAT, QC and Supply.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #558-Scientific
- Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred)