At AbbVie, our mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are recruiting a Incoming QA Compliance Specialist to join our site in Ballytivnan, Sligo. This position will report into the Quality Systems Manager and support the Quality Assurance team.
About the Role
* Ensure that all products leaving AbbVie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
* Complete incoming quality assurance (IQA) release of raw materials, single use assemblies and bulk drug substance.
* Ensure timely release of materials for manufacture of products in compliance with all site policies, procedures and timelines.
* Provide quality oversight of sampling requirements for excipients to ensure aseptic sampling requirements.
* Lead/Assist in investigations arising out of specifications results for IQA materials.
* Coordinate with approved contract laboratories for quotations, processing and release of samples.
* Review/Audit of completed release records.
* Author specifications and standard operating procedures.
* Act as SME during regulatory and internal inspections.
* Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
* 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 Request.
* Drive continuous improvements and simplify site processes and procedures, specifically relating to the Operations function to ensure compliance is maintained at all times.
* Provide other support as deemed necessary.
Requirements
* 3rd level qualification (level 8) in Science, Quality or Engineering.
* 2+ years' experience in a Quality role for incoming materials.
* 3+ years experience in a regulated GMP environment.
* Strong knowledge of regulatory requirements.
About Us
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
We believe in creating a workplace where everyone has the opportunity to thrive. If you're passionate about working for a company that makes a difference, we'd love to hear from you.