What are the responsibilities and job description for the Specialist Quality Assurance position at Abbott?

The Opportunity

This position works out of our Third-Party Manufacturer (TPM) location in Austin, TX within the Diabetes Care division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Abbott Diabetes Team (ADC) team on-site at the TPM consists of a cohesive group of professionals, representing various functions such as Operations, Quality, Engineering (both Site and Global), Program Management, and Supply Chain. This collaborative environment offers a unique opportunity to gain valuable cross-functional insights and experience. Additionally, the Quality Assurance Specialist will play a crucial role in supporting ADC's ambitious business growth. More importantly, you will have a positive impact on the quality of life for the patients we serve, as we strive to deliver 65 million units annually.

As a Quality Assurance Specialist, in this role you will :

Develop Quality Experience : Support high-volume automated manufacturing.

Review & Approve Quality Records : Gain experience with a variety of key quality documents.

Enhance Quality Mindset : Cultivate a strong focus on quality.

Sharpen Critical Thinking Skills : Operate in a fast-past manufacturing environment.

Develop Leadership Skills : Mentor and coach TPM staff.

Acquire Valuable Knowledge : Gain unique insights and experience that can only be obtained in a TPM environment, working withing another company’s quality system in addition to ADC’s quality system.

What You’ll Work On

The primary function of the Quality Assurance Specialist is to assist in maintaining the quality system. The Quality Assurance Specialist will be an integral part of a team supporting a high-volume, fully automated, 24 / 7 TPM manufacturing operation. Working collaborative with TPM Quality and partnering with Operations & Engineering, this role will help ensure that the TPM meets Abbott's quality standards and expectations.

Main Responsibilities :

TPM Maturity :

Develop models that empower the TPM to drive effective problem-solving strategies and investigations.
Implement agreed-upon actions and target reductions with the TPM and execute the plan.

Compliance :

Create sustainable models for the TPM to improve quality control, increase efficiency, enhance reporting, and ensure long-term sustainability in addressing non-conformance issues.

Support and ensure compliance with Quality Management Systems, including nonconformances, document change control, batch release, investigations, and more.

Actively monitor Third Party Manufacturers (TPM) data and support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.

Review and approve TPM GMP-related documentation for compliance, such as nonconformances, batch records, and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications, and other documentation as required.

Support the Corrective Action / Preventive Action (CAPA) process, including the investigation of failures or deviations in the Manufacturing area as required.

Partner with other internal groups to respond to product inquiries and issues.

Collaborate with the TPM to revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.

Cross-functionally collaborate with members of the Program Management, Engineering, and / or Operations teams working on special projects.

Participate on permanent and temporary teams which are process or project driven.

Collect, analyze, and publish quality metrics.

Assist with other support duties as assigned.

Required Qualifications

Bachelor’s Degree In Life Science, Engineering, or closely related discipline or an equivalent combination of education and work experience

Minimum 3 years In Quality or related field experience; Less experience may be appropriate with advanced degree.

Preferred Qualifications

Preferred experience in the Healthcare industry.

Has a history of completing successful projects and driving positive compliance outcomes.

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