QC Bioassay Analyst

<p>Job Description</p><p></p><p>R306281 QC Bioassay Analyst</p><p></p><p>Our Carlow Site has an immediate opportunity for <b><span>QC Bioassay Analysts/ Senior QC Technicians</span></b> to join our <b>Quality Operation Laboratory</b>. As <b><span>QC Bioassay Analyst</span></b> you will perform and review a range of techniques such as immunoassays, cell-based potency bioassays and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.</p><p></p><p>You will ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety, and reliable supply to our customers.</p><p></p><p>Reporting to the Bioassay Manager / Associate Director, the team is working a <b>2-cycle shift pattern</b> of 7am-3pm and 3pm-11pm (Monday-Friday) rotating weekly.</p><p></p><p>Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.</p><p></p><p><b><span>What you will do: </span></b></p><p><b>Bring energy, knowledge, innovation, and leadership to carry out the following:</b></p><ul><li>Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP.</li><li>Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.</li><li>Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.</li><li>Develop, implement, and maintain procedures that comply with appropriate regulatory requirements.</li><li>Ensure that all Quality Systems within the department are adhered to daily.</li><li>Operate as part of the QC team performing the allocated testing and laboratory-based duties.</li><li>Ensure timely completion of all assigned data processing and reviewing.</li><li>Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.</li><li>Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method <span><span>validation/verifications</span></span> and equipment qualifications.</li><li>Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.</li><li>Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.</li><li>Where applicable, review, approve and trend test results.</li><li>Participate in the laboratory aspects of OOS investigations.</li><li>Provide support with audit/inspection requirements to ensure department <span><span>compliance/readiness.</span></span></li><li> Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.</li><li>Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc, </li><li>Work collaboratively to drive a safe and compliant culture in Carlow. </li><li>May be required to perform other duties as assigned.</li></ul><p></p><p></p><p><b><span>What skills you will need:</span></b></p><p><b>In order to excel in this role, you will more than likely have:</b></p><ul><li>Bachelor’s Degree or higher preferred; ideally in a science related discipline.</li><li>Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.</li><li>Knowledge of cGMP.</li><li>Laboratory Quality Systems experience.</li><li>Proficiency in Microsoft Office and job-related computer applications</li><li>Report, standards, policy writing skills</li><li>Understanding of Lean Six Sigma Methodology preferred.</li><li>Immunoassay and cell culture experience preferable.</li><li>Great communicator, decisive decision-maker with a proven ability to deliver excellence.</li><li>Ability to participate in highly effective teams.</li><li>Desire to continuously learn, improve and develop.</li><li>Willingness to support the team and a strong focus on delivering excellence.</li><li>High personal integrity, credibility, energy, and flexibility.</li></