Specialist Quality Assurance

at  Abbott Laboratories

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Life or Physical Science, Biomedical Engineering or closely related discipline is preferred.
• 2 years’ work-related experience with degree or sufficient transferable experience to demonstrate functional equivalence to a degree.
• Knowledge of regulations and standards affecting IVDs and Biologics.
• Good Lab Practice, Good Manufacturing Practice, laboratory duties, PC Skills (Word, Excel, PowerPoint), Data representation.

WHAT YOU WILL DO:

• Assist with administration and ensuring compliance to Quality Management Systems including:
• Complaints Coordination, Batch Release, Exception Reports, CAPA, Document Control, Surveillance, Testing, Batch and Sample Retention and Maintenance, Metrics etc.
• Assist with other support duties as assigned.
• Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.
• Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required.
• Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.
• Maintains product complaint logs to identify and report recurring issues to quality assurance management and product development. Collaborate with other internal groups to respond to product inquiries and issues.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
• Collaborates with members of the Quality Assurance team working on special projects.
• Participate on permanent and temporary teams which are process or project driven.
• Become familiar and subject matter expert on electronic support systems, TraqWise, GQMS, Teamcenter, compliance wire etc.
• Collect analysis and publish quality metrics.
• Provide data for support of budgetary submissions

The role can have responsibility for one or more of the following processes:

• Batch release
• Complaint Coordination
• Metric maintenance
• Surveillance Program
• Testing Program
• Document Control
• Exception Report and CAPA System
• Batch and Sample Retention and Maintenanc