Overview
AbbVie Ballytivnan – QA Manufacturing Compliance Specialist. This role reports to the Quality Operations Lead and supports the Quality Assurance team. The QA Manufacturing Compliance Specialist is responsible for documenting and establishing a quality system that ensures full compliance with regulatory and AbbVie requirements, and for reporting on the effectiveness of the quality system to senior management.
What you will do
* Ensure that all products leaving AbbVie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
* Ensure that products and aseptic process simulations manufactured at AbbVie Biologics Ballytivnan meet the requirements of end users, regulatory authorities, and the company.
* Provide quality and compliance oversight and assistance to the Operations function to manufacture products in compliance with site policies and procedures.
* Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
* Lead or assist in investigations arising from product or manufacturing process non‑compliance.
* Review/audit completed batch records.
* Review manufacturing logs as required.
* Complete quality review of operations documentation (SOPs, JSTMs, risk assessments).
* Complete line clearance activities.
* Complete incoming raw material checks, including product status maintenance (as required).
* Provide Stability Program support, e.g., sample pulls, weekly checks, protocol generation (as required).
* Maintain finished product status, including labeling as required.
* Administer quality logs (e.g., QA Hold, sample requests).
* Lead operations floor daily walk around of manufacturing areas.
* Drive continuous improvements and simplify site processes and procedures related to Operations to ensure ongoing compliance.
* Provide other support as deemed necessary.
Qualifications
What you will need:
* A third level qualification in a science, quality or engineering discipline.
* Minimum 3 years’ experience in a similar role in a pharmaceutical or sterile manufacturing environment (biologics desirable).
* Strong knowledge of regulatory requirements.
* Excellent written and verbal communication skills with strong attention to detail.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only – to learn more, visit the AbbVie join-us equal employment opportunity opportunity page.
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