Investigation Specialist

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks Investigation Specialists to join deviation investigation teams in Rensselaer, NY. These roles handle compliance tasks to complete investigations and implement robust corrective actions for manufacturing operations.

Positions involve independent non-conformance investigations, preparing detailed reports with recommendations, and reviewing batch records under cGMP standards to ensure quality and compliance.

Qualifications

• BS in life sciences, engineering or related field (may substitute proven experience)
• 2+ years of relevant investigation experience for base level
• Senior level requires 5+ years of experience (level determined by experience)

Responsibilities

• Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operations
• Preparing investigation reports with recommendations for medium/high severity non-conformances
• Analyzing and evaluating information captured through investigations; summarizing trends in reports
• Reviewing batch records and logbooks in accordance with cGMP standards to support investigations
• Reviewing, editing, and revising controlled documents to ensure compliance with procedures
• Monitoring production processes to acquire data and track efficiency of changes
• Participating in and/or leading cross-functional study teams to drive results and investigations
• Gathering and trending process-related data to drive consistency and timeliness

Skills

Investigations

cGMP compliance

Data analysis

Education

Bachelor's degree in life sciences or engineering

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.

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 Control

When & Where

• Location: Rensselaer, New York, United States
• Work model: Monday-Friday, 8am-4:30pm

What You’ll Do

• Independently investigating non-conformances and preventing reoccurrences in support of manufacturing operations
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
• Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
• Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
• Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
• Participating in and/or leading cross-functional study teams to get results, support and or author investigations
• Gathering, trending, and analyzing process related data to drive consistency and timeliness

Let’s Find Out If We’re a Fit

• 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 experience

We are committed to building a workplace with an inclusive culture. 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. 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $128,700.00