Sr Associate QC (Sample Management) is required for a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. In July 2015 the site opened a $300million investment, which added significantly to the sites laboratory, filling, packaging and distribution (including cold chain) capabilities. The site is a fast paced, collaborative, team based working environment, where you get an opportunity to work with other highly skilled staff in a strategically important site in the companies global supply chain.
The Sr Associate QC (Sample Management) will:
This role will be responsible for owning, coordinating, facilitating, and undertaking activities pertaining to Sample Management within QC, without direct supervision and as a backup to QC Manager Sample Management. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for Sample Management duties, including release of commercial and global release testing. The role also represents the QC unit by liaising with internal and external stake holders. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the role.
o LIMS lot authorisation of commercial and Global IDP release testing.
o Oversight of ADL Stability programme
o Manage sample management activities across the site
o Create/own and approve protocols, sample plans, SOPs and documentation
o Responsible for SAP and LIMS functions/ transactions within the sample management remit
o Management and maintenance of Reference standards and reserves for the site including Reference Standards and assay controls, training and verification samples
The Sr Associate QC (Sample Management) will require:
o Bachelor’s degree in a Science related field is required.
o 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
Call Amparo in LSC on 0214777 329 to discuss this Sr Associate QC (Sample Management) role in more detail or apply directly via this advert.