Job Description:
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We are seeking a highly skilled QC Bioassay Analyst to perform and review various techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques as part of routine and non-routine testing and project work. The successful candidate will ensure that processes and end products comply with corporate and regulatory requirements for product release.
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The QC Bioassay Analyst will report to the Bioassay Manager/Associate Director and work closely with the Quality Assurance group to ensure that all materials meet incredibly high standards of quality and comply with regulatory requirements.
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Responsibilities:
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* Perform and review techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques.
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* Ensure compliance with company safety policies, cGMP, and cGLP.
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* Develop, implement, and maintain procedures that comply with regulatory requirements.
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* Operate as part of the QC team performing allocated testing and laboratory-based duties.
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* Participate in timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
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* Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
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* Review, approve, and trend test results.
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* Participate in laboratory aspects of OOS investigations.
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* Provide support with audit/inspection requirements to ensure department compliance/readiness.
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* Participate in internal and external audits and inspections.
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* Drive continuous improvement and resolve machine and system issues using standard tools and methods.
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* Collaborate to drive a safe and compliant culture.
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* Perform other duties as assigned.
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Qualifications & Experience:
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* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
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* Knowledge of cGMP.
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* Laboratory Quality Systems.
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* Proficiency in Microsoft Office and job-related computer applications.
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* Report, standards, policy writing skills.
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* Understanding of Lean Six Sigma Methodology (preferred).
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* Immunoassay and cell culture experience (preferred).
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* Strong leadership and interpersonal skills.
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* Ability to participate in highly-effective teams.
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* Desire to continuously learn, improve, and develop.
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* High personal integrity, credibility, energy, and flexibility.
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* Model leadership behaviors and use MPS principles to achieve success.
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* Set clear performance standards and overcome obstacles.
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Education:
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* Bachelor's Degree or higher (preferred); ideally in a science-related discipline.
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