Compliance Specialist (Engineering & Automation)
Company: Regeneron Pharmaceuticals, Inc.
Posted on: November 22, 2021
We are currently looking to fill a Compliance Specialist
(Engineering & Automation) position. This position ensures and
supports cGMP and procedural compliance for the Technical
Operations Engineering & Automation Department. This includes
conducting evaluations against documents and providing mentorship
to others on a variety of cGMP work.In this role, a typical day
might include the following:
- Maintain knowledge of current good manufacturing practices
(cGMPs), Biotech/Pharmaceutical industry rules/emerging draft
guides (GxP), etc. and conduct department relevant evaluations
against these documents.
- Provide support, information and assistance with the
initiation, authorship, completion and follow-up of department
documentation and records such as change control, investigation,
root cause analysis, risk assessment, impact statement,
corrective/prevention action plan, standard operating
procedure/work instruction/job aid, periodic evaluation report,
logbook, maintenance record/work order, lifecycle document,
- Perform periodic review/evaluation of these documents and
records to assess for compliance with established
quality/regulatory standards/requirements, policies and procedures.
Teach/council department members in accurate execution.
- Acts as a liaison between Engineering & Automation and
Quality/Regulatory groups to identify and address compliance
- Find opportunities for continuous improvement of compliance and
support/lead improvement initiatives.
- Author responses, and track/trend results of department
quality/compliance and regulatory audits/inspections.This role may
be for you if you:
- Have solid understanding of cGMP biotech/pharma manufacturing
operations/laboratory testing, regulatory and quality requirements,
Root Cause Determination and Risk Management Techniques, procedures
and documentation methods.
- Are able to manage multiple tasks and meet goals.
- Are able to speak to large groups (including senior management
and regulatory agencies).
- Possess excellent writing, communication and interpersonal
skills.To be considered for this role you must hold a Bachelor's
degree in science or engineering and the following minimum amounts
of related experience for each level:
- Associate Specialist - 0-2+ years
- Specialist - 2+ years
- Senior 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 amazing
benefits including health and wellness programs, fitness centers
and stock for 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 maternity 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.#REGNQA
Keywords: Regeneron Pharmaceuticals, Inc., Troy , Compliance Specialist (Engineering & Automation), Engineering , Troy, New York
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