Specialist, Manufacturing Quality Assurance

About AbbVie

AbbVie is dedicated to discovering and delivering innovative medicines and solutions that address serious current and future health challenges. Its impactful work spans key therapeutic areas such as immunology, oncology, and neuroscience, alongside offerings within the Allergan Aesthetics portfolio.

Role Overview

Located at AbbVie Ballytivnan in County Sligo, Ireland, this role involves joining the Quality Assurance team to ensure manufacturing compliance and quality standards. Reporting to the Quality Operations Lead, the Specialist in Manufacturing QA will establish, document, and uphold a quality system that aligns fully with both regulatory mandates and AbbVie's internal requirements. This position entails shift-based work.

Key Responsibilities

• Guarantee that all pharmaceutical products leaving AbbVie Biologics Ballytivnan meet required standards for marketed and investigational drugs.
• Confirm that aseptic processes and manufactured products comply with end-user, regulatory, and company requirements.
• Deliver quality and compliance oversight for the Operations team to ensure manufacturing aligns with site policies and procedures.
• Oversee aseptic processing workflows, including aseptic intervention monitoring.
• Lead or assist in investigations of manufacturing non-compliance issues.
• Perform detailed reviews and audits of batch records.
• Examine manufacturing logs as necessary.
• Conduct quality reviews of operational documents, such as SOPs, Job Safety Task Matrices, and risk assessments.
• Execute line clearance activities diligently.
• Oversee incoming raw material inspections and maintenance of product status as required.
• Support the stability program by executing sample collections, weekly monitoring, and protocol development when necessary.
• Manage finished product labeling and status maintenance.
• Administer quality logs, including QA Holds and sample requests.
• Lead daily operational floor walkthroughs across manufacturing areas.
• Champion continuous improvement initiatives and streamline procedures within the Operations function to ensure consistent compliance.
• Provide additional support as needed.

Required Qualifications

• Possession of a third-level degree in science, quality assurance, or engineering discipline.
• Minimum of three years’ professional experience in a similar capacity within pharmaceutical or sterile manufacturing environments; biologics experience is advantageous.
• Comprehensive understanding of regulatory requirements governing pharmaceutical manufacturing.
• Strong written and verbal communication abilities paired with keen attention to detail.

Additional Information

AbbVie is committed to equal employment opportunity and integrity in operations. The company embraces diversity and supports innovation, community service, and transparency. This role requires shift work and is based onsite in Sligo, Ireland.