Specialist Quality Assurance

3 weeks ago

Chicago, United States Abbott Laboratories Full time

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.

**The Opportunity**

This role will conduct quality-related activities in Complaint Handling to deliver consistent high-quality documents, services, products and processes, which adds value to the business.

The primary function of the Quality Specialist is to assist in maintaining the quality system.

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 Maintenance

**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.
- Collect analysis and publish quality metrics.
- Provide data for support of budgetary submissions

**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 WE OFFER**

At Abbott, you can have a good job that can grow into a great career. We offer:

- ** A FAST-PACED WORK ENVIRONMENT** where your safety is our priority (Include for Manufacturing roles only)
- ** TRAINING AND CAREER DEVELOPMENT**, with onboarding programs for new employees and tuition assistance
- ** FINANCIAL SECURITY** through competitive compensation, incentives and retirement plans
- ** HEALTH CARE AND WELL-BEING PROGRAMS **including medical, dental, vision, wellness and occupational health programs
- ** PAID TIME OFF**:

- ** 401(K) **retirement savings with a generous company match
- ** THE STABILITY OF A COMPANY **with a record of strong financial performance and history of being actively involved in local communities

The base pay for this position is $64,000.00 - $128,000.00. In specific locations, the pay range may vary from the range posted.

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