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Incoming QA Compliance Specialist
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AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Innovate with intention.
Science is at the heart of what we do. People are at the heart of why we do it.
Welcome to AbbVie
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. Redefining what is possible is our business and our passion. 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.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities would be:
1. Ensure that all products leaving AbbVie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
2. Complete incoming quality assurance (IQA) release of raw materials, single use assemblies and bulk drug substance.
3. Ensure timely release of materials for manufacture of products in compliance with all site policies, procedures and timelines.
4. Provide quality oversight of sampling requirements for excipients to ensure aseptic sampling requirements.
5. Lead/Assist in investigations arising out of specifications results for IQA materials.
6. Coordinate with approved contract laboratories for quotations, processing and release of samples.
7. Review/Audit of completed release records.
8. Author specifications and standard operating procedures.
9. Act as SME during regulatory and internal inspections.
10. Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
11. Provide Stability Program Support, e.g., sample pulls, weekly checks, protocol generation (as required).
12. Maintain finished product status, including labeling as required.
13. Administer Quality Logs, e.g., QA Hold, Sample Request.
14. Drive continuous improvements and simplify site processes and procedures, specifically relating to the Operations function to ensure compliance is maintained at all times.
15. Provide other support as deemed necessary.
Qualifications
What you will need:
- 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.
Additional Information
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. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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