Job Description We are currently hiring a QC Metrology & Informatics Chemist to join our team in Clonshaugh in Dublin for a Fixed Term Contract of 12 months. The QC metrology & Informatics chemist is responsible for assisting in the management and qualification of laboratory instrumentation and computer systems through the relevant quality systems to the effective/final state ready for use.
This person oversees and serves as a super user/resource for Abbvie QC for the ALEXIS LIMS, Empower, VelQuest Smartlab software and any other laboratory software systems.
The QC metrology & Informatics support chemist performs GMP data review of laboratory projects associated with equipment calibration and preventative maintenance records.
This person is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements, and comply with all SOPs and Abbvie policies and procedures in the performance of job duties.
This position reports to the QC Supervisor.
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. Qualifications Bachelor's Degree or above in Chemistry or related Science 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.
Demonstrate strong organizational skills and the ability to communicate across multiple departments Demonstrate strong analytical laboratory skills and laboratory troubleshooting abilities.
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