Job Description
Within this role you will perform sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment. As a Temp QC External Lab Coordinatora typical day might include, but is not limited to, the following: Planning, prioritising and coordinating sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment Using our sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to determine accuracy and to maintain sample integrity Working as part of a team to ensure that samples are delivered to the laboratories on-time Coordinating the issuance and approval of Quality Agreements with the contract labs and author Master Service Agreements, as necessary Participating as required by QA in GMP audits to the contract labs Documenting and communicating discrepancies to appropriate personnel in a timely and efficient manner Ensuring that all work carried out is in compliance with the required regulatory standards, and conforms to company policies and standard operating procedures (SOPs) Reviewing and approving method transfer validation protocols and reports Assisting the external laboratories in troubleshooting and identifying root cause analysis to provide technical advice as needed Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT Initiating and completing CAPAs and Change Controls in accordance with site procedures This role might be for you if: You have a proven ability to work independently or as part of a team You possess strong trouble-shooting and problem solving skills You have strong attention to detail & excellent written and oral skills To be considered for this role, you must hold a third level qualification (BSc degree or higher) in biology, chemistry, microbiology or a related field with relative experience (preferably in the pharmaceutical or biotechnology industries). Will substitute relevant work experience in lieu of degree requirement. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.