Sr. Associate QC - NPI

<h2><b>Career Category</b></h2>Quality<h2></h2><h2><b>Job Description</b></h2><p><b>Quality Control NPI Snr Associate </b></p><p><b>Level 4</b></p><p><b>Amgen Dun Laoghaire </b></p><p></p><p></p><p><b>Primary Responsibilities:</b></p><ul><li>QC Representative for NPI activities and routine Product meetings</li><li>Assist with activities related to QC projects and/or QC tasks within Site projects</li><li>Plan and perform non-core testing related to NPI activities</li><li>Manage all sample management activities related to NPI activities throughout the site </li><li>Create/own and approve protocols, sample plans, SOP and documentation related to NPI </li><li>QC Representative responsible for Method Validation and Transfers co-ordination and readiness</li><li>Responsible for their own training and safety compliance.</li><li>Sample shipments and temperature monitoring activities for NPI activities</li><li>LIMS data coordination of non-core (NPI) activities.</li></ul><p></p><p><b>Job Summary:</b><br/>Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.</p><ul><li>Contributes to team by ensuring the quality of the tasks/services provided by self</li><li>Contributes to the completion of milestones associated with specific projects or activities within team</li></ul><p>This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.</p><p></p><p><b>Specific Job Duties:</b><br/>• With a high degree of technical flexibility, work across diverse areas within QC<br/>• Plan and perform analyses with great efficiency and accuracy.<br/>• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.<br/>• Report, evaluate, back-up/archive, trend and approve analytical data.<br/>• Troubleshoot, solve problems and communicate with stakeholders.<br/>• Initiate and/or implement changes in controlled documents.<br/>• May train others as necessary<br/>• Participate in audits, initiatives and projects that may be departmental or organizational in scope.<br/>• Write protocols and perform assay validation and equipment qualification/ verification.<br/>• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.<br/>• May contribute to regulatory filings.<br/>• May conduct lab investigations as necessary.<br/>• Evaluate lab practices for compliance on a continuous basis.<br/>• Approve lab results<br/>• May represent the <span>department/organization</span> on various teams<br/>• May interact with outside resources.<br/>• Create APPX data files and randomisation memo to facilitate data analysis.<br/>• LIMS data coordination of commercial and import testing on site where applicable<br/>• May provide technical guidance. May contribute to regulatory filings.<br/>• May represent the <span>department/organization</span> on various teams. May train others.<br/>• May interact with outside resources<br/> </p><p></p><p><b>Basic Qualifications &amp; Experience:</b></p><p></p><p><b>Qualifications </b></p><ul><li>Bachelor’s degree in a science discipline.<br/>2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.</li><li>Strong background in Chemistry and Analytical testing is required.</li><li>Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.</li></ul><p><b>Knowledge:</b></p><ul><li>Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.  Deepens technical knowledge through exposure and continuous learning</li><li>Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery</li></ul><p><b>Problem Solving:</b></p><ul><li>Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information<ul><li>Qualitative information</li><li>Quantitative research</li><li>Trend data</li></ul></li><li>Anticipates and prevents potential problems</li></ul><p><b>Skills:</b></p><p>• Take initiative to identify and drive improvements<br/>• Communication skills (verbal and written) at all levels</p><ul><li>Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)</li><li>Presentation skills</li><li>Escalate issues professionally and on a timely basis</li></ul><ul><li>Decision making</li><li>Teamwork and Coaching others</li><li>Teamwork and Coaching others</li><li>Auditing documentation and operation process</li></ul><p><b>Competencies: </b></p><ul><li>Demonstrated ability to work independently and deliver right first-time results</li></ul><p>Works under minimal direction Work is guided by objectives of the department or assignment</p><p>Follows procedures</p