QA Compliance Specialist

Job Description

I chose AbbVie.

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I chose the No 1 Great Place to Work in 2020

Choose AbbVie

We focus on new and innovative technologies that deliver products and processes that make a difference worldwide. We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well. Choose AbbVie if you share our passion for improving the health and lives of patients.

At AbbVie Ballytivnan , we are expanding our facility with a new state of the art biologics plant that will bring ground breaking scientific research to real life solutions for our patients. We are now sourcing a QA Compliance Specialist to join our team on a permanent basis.

In this role, you will:

• Assists with planning and conducting internal compliance audits of all operations within the facility.
• Provides support with company and regulatory agency (i.e. DEA, FDA) inspections.
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Assist with management review and associated metrics for the plant
• Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s).
• Responsible for supplier qualifications including new suppliers, changes and re-qualifications.

• Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• 3+ years of Biopharmaceutical experience
• Quality Assurance/Regulatory Affairs/Compliance is preferred
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• Must have some knowledge of plant and company level procedures.
• Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
• Ability to identify and investigate problems and help to resolve them.

AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. Additional Information

• Travel: No
• Job Type: Experienced
• Schedule: Full-time
• Job Level Code: IC