Quality Associate I
AbbVie
Summary
This job works under moderate supervision to apply practical professional knowledge of the Quality Assurance area to execute assigned tasks and manage defined project or process components including non-conformance investigations. Responsible for completing investigations including Root Cause Analysis and action plans.
Job description
Key Responsibilities
This job supports project outcomes including non-conformance investigation by completing defined tasks, collaborating with project leads and stakeholders, and following established processes and compliance requirements.
- Collaborates with colleagues to investigate non-conformance events, perform root cause analysis, action planning and assessments, ensuring processes are executed accurately and align with quality standards.
- Analyzes non-conformance (NC) events and NC trends to identify recurring issues and flag potential compliance risks for escalation and proper investigation.
- Conducts review of NC events such as verifying prior corrective action implementations per event and adherence to procedural requirements, to maintain process reliability.
- Develops detailed reports and records that clearly summarize audit Non-Conformance CAPA status and deviation data for review.
- Contributes to practical recommendations to improve specific processes, reduce recurring nonconformances, and support adherence to quality procedures.
Requirements
- Bachelors Degree in Engineering, science or closely related discipline is desired or equivalent technical experience plus demonstrated competence
- Desired 5+ years of significant engineering/operational/laboratory experience
- Has demonstrated competency within a discipline
- Possesses strong technical knowledge and application of concepts, practices, and procedures
- Works on problems of complex scope where analysis of situations or data involves multiple competing factors
- Demonstrates judgment within defined procedures and practices to determine appropriate action
- Interacts well with diverse groups within manufacturing, operations and QA
- Maintains strong working relationships with internal and external collaborators
- Listens to and understands others points of view and articulates tactfully and respectfully one's own perspective orally, in writing and in presentations
- Works well with other colleagues in a collaborative fast-paced goal driven environment
- Possesses interpersonal skills to negotiate and reconcile differences
- Has a technical background in medical devices, pharmaceutical, biologics or similar industries (preferred)
Benefits
- Paid time off
- Vacation
- Holidays
- Sick leave
- Medical, Dental & Vision
- 401(k)
- Short-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.