Compliance Specialist-Technical Operations
Company: Regeneron Pharmaceuticals, Inc.
Location: Rensselaer
Posted on: July 18, 2025
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Job Description:
Our Technical Operations Investigations team is hiring! As a
Compliance Specialist you will be an integral part of maintaining
the high standards of compliance and quality across our
manufacturing and IOPS Site Operations. You will collaborate with
cross-functional teams, lead investigations, and implement robust
corrective action plans throughout our Engineering, Automation, and
Facilities departments. In this role, a typical day might include
the following: Independently investigating non-conformances and
preventing reoccurrences in support of manufacturing operations
Reviewing equipment drawings, schematics, life cycle documents, and
automation programming Evaluating and ensuring compliance of SOPs,
work instructions, batch sheets, manufacturing records, and
logbooks with cGMP standards Communicating findings and
recommendations at group meetings Reviewing completed batch records
and logbooks in accordance with cGMP standards in support of
investigations 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 Preparing detailed
investigation reports, including event details, root cause
analysis, product impact assessment, and corrective action
recommendations This role may be for you if you: Excel in a quality
driven organization Have proficiency in root cause analysis and
risk evaluation Can prioritize multiple assignments and changing
priorities Have knowledge of equipment specification requirements
To be considered for this role you must hold a Bachelors degree in
Engineering, or related field and the following minimum amounts of
relevant experience for each level: Specialist 2 years Senior
Specialist 5 years May substitute proven experience for education
requirement. Level is determined based on qualifications relevant
to the role. 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) $66,400.00
- $126,800.00
Keywords: Regeneron Pharmaceuticals, Inc., Westfield , Compliance Specialist-Technical Operations, Engineering , Rensselaer, Massachusetts
