Company Description
A global, research-based biopharmaceutical company combining the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care.
Job Description
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.
Responsibilities:
* 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.
Qualifications
To be successful, you will need:
* A 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.
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.