Rensselaer, NY, 12144, USA
3 days ago
Principal IT Applications Analyst - QC Operations
Within this role you will provide expertise in the administration, maintenance, and lifecycle of computerized systems software and firmware to meet cGMP and procedural requirements for Regeneron’s Industrial Operation and Product Supply (manufacturing) organization. As a Principal IT Applications Analyst within the Operations team of Lab Systems, a typical day might include, but is not limited to, the following: + Coordinating across business departments and stakeholders, gathering, and implementing enhancement requests across departments + Acting as a Technical SME/Lead on initiatives + Investigates and resolves computer software and hardware issues + Ensure systems remain in compliant state - Process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation, and quality risk assessments. + Initiate, author, review documents such as Change Controls, EOE’s, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. + Participate/lead/author investigations and root cause analysis for department issues of non-compliance. + Working with Quality departments to ensure IT Applications are maintained following development life cycle approach + Configuration management and recipe/method management. + Identify areas for continuous improvement in business processes, administrative procedures, and/or configurations/architecture standards + Ensuring data is backed up, and tested, or archived to ensure systems can meet defined RTO (Recovery Time Objective) and RPO (Recovery Point Objective). + Training other IT Applications team members and providing on-the-floor guidance and support to employees + Prioritizing the day-to-day work assignments for analysts within the IT department to support application troubleshooting activities + Maintaining up to date training records for self and direct reports This role may be for you if: + You enjoy both collaborating with a team as well as working independently to develop sustainable solutions to complex problems + You have a proven focus on customer service and have stellar organizational skills. + Have a solid grasp of System Design Lifecycle and Quality Risk Management + You have strong analytical and organizational skills, as well as excellent written and verbal communication skills + You have a degree of ingenuity, creativity, and resourcefulness in an evolving and sometimes ambiguous environment + Are familiar with regulatory and quality policies, procedures, and documentation methods, ideally in cGMP biotech/pharma operations To be considered for this opportunity you should have a BS/BA degree in Information Technology or related field and + Senior IT Applications Analyst: 5 years of progressive industry/relevant experience or equivalent combination of education and experience + Principal IT Applications Analyst: 8 years of progressive industry/relevant experience + May consider experience in lieu of education; level decided upon completion of an interview process + Regulated industry background preferred 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.S.-based 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. **Salary Range (annually)** $77,600.00 - $148,400.00
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