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Compliance Specialist (Engineering & Automation)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Oct 29, 2021

Job Details

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, policies, etc.

  • 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 related issues.

  • 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+ 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 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

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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