Join a mission-driven organization focused on quality and operational excellence. Collaborate with cross-functional teams to enhance processes and compliance. Gain valuable experience in an FDA-regulated environment with growth potential.
Contractor Quality Associate, Biologics
in Healthcare + Life Sciences ContractJob Detail
Job Description
Overview
- Join a dynamic team as a Contractor Quality Associate in Biologics, contributing to quality assurance and operational efficiency.
- Support data migration, batch record review, and release activities to ensure compliance and accuracy.
- Collaborate with cross-functional teams to develop tools for monitoring key performance indicators.
- Utilize document management systems like Veeva Vault and Excel to enhance processes.
- Contribute to the transition of legacy records and maintain traceability and completeness.
- Work in an FDA-regulated environment, ensuring adherence to industry standards and regulations.
- Opportunity for contract extension up to three years with potential for permanent conversion.
- Be part of a mission-driven organization focused on patient-first values.
Key Responsibilities & Duties
- Lead and manage migration of quality documents into Veeva Vault, ensuring compliance.
- Support transition of legacy records while maintaining traceability and completeness.
- Build and maintain trackers for monitoring KPIs, batch records, and release metrics.
- Assist in batch record reviews to ensure compliance and readiness for release.
- Coordinate documentation readiness and collaborate with QA and cross-functional teams.
- Utilize Power BI for data visualization and reporting to enhance operational insights.
- Ensure adherence to quality standards and FDA regulations within the pharmaceutical industry.
- Provide technical writing support and contribute to organizational communication efforts.
Job Requirements
- Associate degree required; BS/BA in life sciences or related field preferred.
- Minimum of 3 years of experience in Quality Assurance within FDA-regulated industries.
- Proficiency in batch record review, document control, and release processes.
- Familiarity with SAP inventory systems and Veeva Quality systems.
- Strong organization, communication, and technical writing skills.
- Self-directed, goal-oriented, and quality-conscious professional mindset.
- Ability to work cross-functionally with QA, MSAT, QC, and Supply teams.
- Knowledge of Power BI for data visualization and reporting is preferred.
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