Facilities Compliance Specialist

Rensselaer, NY, United States
Aug 05, 2019
Required Education
Associate Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Ensures cGMP compliance for the Rensselaer Facilities Management Department.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.

• Manages and participates in Facilities Department issues of non-compliance (NOEs, EOEs, and DNFs). Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.

• Facilitates reviews and revisions of Facilities Department related Standard Operating Procedures, Work Instructions, Risk Assessments, and OJT Task Evaluations for each group within the Department.

• Manages and provides support, information, and assistance to individuals and groups with the initiation, review, submission, and follow-up of documents such as Change Controls and Corrective and Preventive Action plans.

• Provides periodic review of Facilities Department documentation and records such as logbooks and maintenance work records to assess for compliance with established quality standards, policies, and procedures.

• Participates in, and obtain results of, all Facilities Department quality and regulatory audits.

• Provides support and training for Facilities personnel on regulatory and quality topics, such as proper documentation procedures and the use of QUMAS.

Education and Experience:

• Associate Level- BA/BS required, preferably in an engineering or scientific related field, with 0-2 years of relevant experience

• Mid-Level - BA/BS required, preferably in an engineering or scientific related field, with 2+ years of relevant experience

• Senior Level - BA/BS required, preferably in an engineering or scientific related field, with 5+ years of relevant experience

Will substitute relevant experience in lieu of educational requirements.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.