Quality Associate

Job Description

Job Summary:

• The Contractor Quality Associate, 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.
• The position requires familiarity with Veeva Vault or similar document management systems and Power BI.
• While Power BI proficiency is preferred, it is not a mandatory requirement for the role.

Duties and 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.

Education:

• Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred).

Experience:

• 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.

Knowledge, Skills Abilities:

• Strong organization and communication skills and technical writing skills.
• Familiarity with SAP inventory system.
• Proficient in Microsoft Office tools, and Veeva Quality systems.
• Must be self-directed, goal-oriented, and quality conscious.
• Ability to work cross-functionally with QA, MSAT, QC and Supply.
• Values consistent with client Values (Integrity, Respect, Professionalism, Quality and Teamwork); together with an intrinsic understanding of client’s Mission and the need to always think first of the Patient.