Quality Associate

The Quality Associate Contractor, Biologics will play a key role in supporting data migration, batch record review, release activities, and building trackers to enhance operational efficiency. This position requires strong attention to detail, familiarity with document management systems such as Veeva Vault, and proficiency in Excel. Experience in Quality Assurance is essential, and knowledge of Power BI is preferred to support data visualization and reporting. The associate will collaborate with cross-functional teams to ensure accurate documentation, timely release of batches, and development of tools to monitor key performance indicators.

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.

Qualifications:

The position requires familiarity with Veeva Vault or similar document management systems and Power BI. While Power BI proficiency is preferred

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.