Specialist, QA
Summary
QA Specialist in AbbVie's Dublin QC laboratory building and maintaining LIMS configurations (ALEXIS, Labware, VelQuest Smartlab), reviewing analytical data, and drafting validation/SOP documentation under FDA, GLP, cGMP and QSR requirements.
- Primary duties and responsibilities of the position are as follows. Other duties may be assigned.
- Build and maintain specifications in the ALEXIS LIMS system.
- Build and maintain sessions in VelQuest Smartlab
- Administration of laboratory software systems.
- Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOP’s and specifications.
- Draft, review, and approve validation and qualification documentation for analytical software.
- Draft, review, and approve SOPs, forms, and associated documentation with analytical equipment.
- Management of laboratory instruments and standards through Labware LIMS.
- Perform routine review of documentation generated by the QC laboratory, such as auditing laboratory data and supporting documentation (instrumental printouts, COAs, chemist notebooks, cumulative stability tables, protocols, reports, laboratory investigations, analytical test methods etc.) generated to support equipment qualification and calibration for accuracy, completeness, and compliance to requirements.
- Initiate and facilitate Change Management Requests.
- Author documents that ensure cGMP compliance, such as analytical test methods, analytical test method development reports, method validation protocols and reports, method verifications protocols and reports, and instrumentation qualification documentation (URS/IQ/OQ/PQ).
- Seek process innovation and continuous process improvement in laboratory area.
- Complete and conform to all training requirements for job role, including company-required and job-specific training.
- Bachelor’s Degree or above in Chemistry or related Science Abbvie
- Experience:
- 3-5 years relevant Quality Control experience or equivalent combination of education and experience
- Experience in pharmaceutical manufacturing facility.
- Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
- Demonstrate competency in review of data generated by QC laboratory as attention to detail is a requirement of the position.
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.
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