Investigation Specialist

Summary

Build our future together: Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're seeking Investigation Specialists to join our deviation investigation teams. These positions perform all compliance related tasks vital to completing investigations and implementation of robust corrective actions for supporting manufacturing operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.Current Departments with Openings Technical Operations Quality ControlLocation & Work Model Location: Rensselaer, New York, United StatesWork model: Monday-Friday, 8am-4:30pmWhat you'll do Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operationsPreparing investigation reports that include recommendations on investigation findings for medium/high severity non conformancesAnalyzing and evaluating information captured through investigations, summarizes information and trends in investigation reportsReviewing completed batch records and logbooks in accordance with cGMP standards in support of investigationsReviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written proceduresMonitoring production processes to acquire vital data in support of investigations and track efficiency of changesParticipating in and/or leading cross-functional study teams to get results, support and or author investigationsGathering, trending, and analyzing process related data to drive consistency and timelinessRequirements Requires B.S in life sciences, engineering or related field, may substitute proven experience for education requirement, and the following amount of related experience for each level: Associate Investigation Specialist: 0-2+ years of experience Investigation Specialist: 2+ years of experience Senior Investigation Specialist: 5+ years of experience Level will be determined based on experienceDoes this sound like you?Equal Opportunity Statement 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.Benefits Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.Background Checks As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.Salary Salary Range (annually) $62,355.00 - $128,700.00Company Overview Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.For jobs in Canada: this posting is for an existing position.#J-18808-Ljbffr

Job Description

Build our future together: Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're seeking Investigation Specialists to join our deviation investigation teams. These positions perform all compliance related tasks vital to completing investigations and implementation of robust corrective actions for supporting manufacturing operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.Current Departments with Openings Technical Operations Quality ControlLocation & Work Model Location: Rensselaer, New York, United StatesWork model: Monday-Friday, 8am-4:30pmWhat you'll do Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operationsPreparing investigation reports that include recommendations on investigation findings for medium/high severity non conformancesAnalyzing and evaluating information captured through investigations, summarizes information and trends in investigation reportsReviewing completed batch records and logbooks in accordance with cGMP standards in support of investigationsReviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written proceduresMonitoring production processes to acquire vital data in support of investigations and track efficiency of changesParticipating in and/or leading cross-functional study teams to get results, support and or author investigationsGathering, trending, and analyzing process related data to drive consistency and timelinessRequirements Requires B.S in life sciences, engineering or related field, may substitute proven experience for education requirement, and the following amount of related experience for each level: Associate Investigation Specialist: 0-2+ years of experience Investigation Specialist: 2+ years of experience Senior Investigation Specialist: 5+ years of experience Level will be determined based on experienceDoes this sound like you?Equal Opportunity Statement 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.Benefits Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.Background Checks As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.Salary Salary Range (annually) $62,355.00 - $128,700.00Company Overview Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.For jobs in Canada: this posting is for an existing position.#J-18808-Ljbffr