Job Opportunity
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LSC have a great contract opportunity for a QC Senior Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
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If you have 5 years of experience in construction management/engineering within the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you Key Responsibilities:
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* Perform Stability Program related activities such as pulling stability samples, study initiations.
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* Create/own and approve protocols, sample plans., SOPs, training manuals.
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* Perform SAP, LIMS and CIMS functions/transactions within the sample management remit.
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* Out of hours responder for sample management equipment (fridges /freezers / incubators).
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* Responsible for their own training and safety compliance.
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* Sample shipments and temperature monitoring activities.
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* LIMS data coordination of commercial and import batches.
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* Management and maintenance of the Site Inventory of Reference Standards, Assay Controls, Training and Verification samples.
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Specific Job Duties:
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* Liaise with site Planning, Manufacturing and Inspection regarding ADL manufacturing schedule and required QC testing.
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* Liaise with Stability Product Representatives and Product Quality Leads as required.
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* Perform routine sample management tasks as per procedures.
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* With a high degree of technical flexibility, work across diverse areas within QC.
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* Plan and perform multiple, complex routine/non-routine tasks with efficiency and accuracy.
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* Report, evaluate, back-up/archive, trend and approve data.
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* Troubleshoot, solve problems and communicate with stakeholders.
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About You - Are Your Skills a Match?
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* Bachelor's degree in a Science related field is required.
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* 5+ 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.
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* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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* Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1 G or a Stamp 4 visa.
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* Please note that we are unable to provide visa sponsorship.
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Thank you for your understanding. Apply via this advert or contact Grinne Hodnett for any questions about this opportunity Skills: Quality Control LIMS SAP