Quality Associate
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.
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
Education:
• Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred)Technical:
• 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. Must Possess:
• 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.
• Values consistent with the companies Values (Integrity, Respect, Professionalism, Quality and Teamwork); together with an intrinsic understanding of the Mission and the need to always think first of the Patient. Pay ranges between $35-42/hr based on experience
Recommended Jobs
Afternoon Babysitter for Preschooler
We are seeking a nurturing and energetic babysitter for our 3.5-year-old child in Greenbelt, Washington, DC. The position is for the current school year, running from October 1, 2025, to June 15, 2026…
Community Coordinator
Department: Operations Location: Dock 1053 Description The Community Coordinator serves as the welcoming face of Dock 1053, creating a warm, member-focused environment while ensuring the camp…
Quality Assurance Intern - Summer 2026
What you’ll do Gain hands-on experience in a chemical manufacturing environment Lead or support process improvement projects to enhance quality and efficiency Investigate failed batches to i…
Family Nurse Practitioner Position 35 Miles West of Raleigh, North Carolina
A reputable, physician-led, not-for-profit healthcare organization has an opening for a Family Nurse Practitioner at their clinic just 35 miles West of Raleigh, North Carolina. This is an outpatient-…
Senior Business Development Manager => Relocate to TW
Job Description: -Responsible of all sales, marketing, communication and advertisement activities. -Ensure the company’s promotion image (brand awareness) on the market. -Participate in the cho…
Manager, Strategic Sourcing, Industrial Gasses
Requisition Number: 71494 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the dep…
Physicist - Rex Radiation Oncology
Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary: Provides both routine and…
Dishwasher
Founded in 1991, Logan's Roadhouse revisits the classic roadhouse from days past and brings it to life in a modern way through its welcoming hospitality, attentive service and kickin', upbeat atmosph…
Corporate - Warehouse Associate
Job Description Job Description Rite Rug has been one of the top privately owned flooring companies for 90 years! We are looking for a Warehouse Associate to join our growing team! $19 to…