Compliance Specialist (External Manufacturing)
Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: January 22, 2023
Job Description:
We are currently looking to fill a Compliance Specialist,
External Manufacturing position. This position is a member of the
External Manufacturing Team and is responsible for operations
support and compliance related activities for the manufacture of
Regeneron products.In this role, a typical day might include the
following:
- Leading and handling deviation investigations, CAPAs, and
change controls
- Reviewing and maintaining procedures, polices and other
instructional documents with a focus on continuous improvement
- Generating and tracking performance metrics
- Maintaining knowledge of current good manufacturing practices
(cGMPs)
- Conducting periodic reviews of Drug Product Manufacturing
documentation and records to assess for compliance with established
quality standards, policies and procedures
- Maintaining required training status on Regeneron specific work
instructions and SOPs
- Assisting in maintenance of product integrity and company
reputation by assisting in the monitoring of cGMP compliance at
drug product contract manufacturers
- Continuous Process Improvement ImplementationThis role may be
for you if you:
- Have knowledge of drug product manufacturing from formulation
through the final package
- Possess basic knowledge of regulatory compliance inclusive of
cGMP, FDA regulations, familiarity with ICH guidelines and EU
regulations
- Exhibit confidence, have a high emotional IQ, and have strong
interpersonal, written and oral communication skills for providing
team updates
- Like collaborating with external vendors and partners
- Enjoy travel to contract manufacturers or business partners, as
the need arises (25% or less)To be considered for this role you
must hold a Bachelor's degree in scientific discipline and the
following amount of related experience in cGMP manufacturing
operations (clinical and/or commercial drug products) for each
level:
- Associate Compliance Specialist: 0-2+ years
- Compliance Specialist: 2+ years
- Sr Compliance Specialist: 5+ yearsMay 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 steps toward living the Regeneron Way! We
have an inclusive and diverse culture that provides comprehensive
benefits including health and wellness programs, fitness centers
and 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. We will ensure
that individuals with disabilities are provided reasonable
accommodations to participate in the job application process.
Please contact us to discuss any accommodations you think you may
need.The salary ranges provided are shown in accordance with U.S.
law and apply to U.S. based positions, where the hired candidate
will be located in the U.S. If you are outside the U.S, please
speak with your recruiter about salaries and benefits in your
location.Salary Range (annually) $55,700.00 - $121,300.00
Keywords: Regeneron Pharmaceuticals, Inc., Troy , Compliance Specialist (External Manufacturing), Other , Troy, New York
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