Description
PE Global is currently recruiting for a Sr QC Associate on behalf of a leading biotech company based in Dublin South.
This is an initial 12-month contract role.
Job Summary
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
Contributes to team by ensuring the quality of the tasks/services provided by self
Contributes to the completion of milestones associated with specific projects or activities within team
This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
Responsibilities
With a high degree of technical flexibility, work across diverse areas within QC
Plan and perform analyses with great efficiency and accuracy.
Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
Report, evaluate, back-up/archive, trend and approve analytical data.
Troubleshoot, solve problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents.
Participate in audits, initiatives and projects that may be departmental or organizational in scope.
Write protocols and perform assay validation and equipment qualification/ verification.
Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
May contribute to regulatory filings.
May conduct lab investigations as necessary.
Evaluate lab practices for compliance on a continuous basis.
Approve lab results
May represent the department/organization on various teams
May interact with outside resources.
Create APPX data files and randomisation memo to facilitate data analysis.
LIMS data coordination of commercial and import testing on site where applicable
May provide technical guidance.
May train others.
Education and Experience
Bachelor's degree in a science discipline.
2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
Strong background in Chemistry and Analytical testing is required.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.
Deepens technical knowledge through exposure and continuous learning
Apply
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on ********** or alternatively send an up to date CV to ******
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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