Incoming QA Compliance Specialist
Incoming QA Compliance Specialist
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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 researchbased biopharmaceutical company that combines the focus and passion of leadingedge 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 as an Incoming QA Compliance Specialist would be:
- 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.
- Leading / Assisting in investigations arising out of specifications results for IQA materials
- Lease with approved contract laboratories for quotations processing and release of samples.
- Review/Audit of completed release records.
- Authoring specifications and standard operation procedures
- Acting as SME during regulatory and internal inspections
- Completion of quality review of operations documentation (SOPs JSTMs Risk Assessments)
- Provide Stability Program Support e.g. sample pulls weekly checks protocol generation (as required).
- Finished product status maintenance including labelling as required.
- Administration of Quality Logs e.g. QA Hold Sample Request.
- Drive continuous improvements and simplify site processes and procedure specifically relating to the Operations function to ensure compliance is maintained at all times.
- 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 AbbVies 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.
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US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
