Compliance Specialist (Engineering)

Location
Rensselaer, NY, United States
Posted
Sep 24, 2019
Ref
17697BR
Required Education
Bachelors 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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Responsible for ensuring cGMP compliance for the Rensselaer Tech Ops Engineering & Automation Department.
*Level to be determined based on qualifications relevant to the role*
Essential Duties and Responsibilities include, but are not limited to, the following:

• Facilitates reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.

• Acts as a liaison between Engineering & Automation and onsite quality and regulatory groups to define and address compliance related items.

• Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.

• Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans.

• Participates in investigations and root cause analysis for department issues of non-compliance.

• Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. to assess for compliance with established quality standards, policies and procedures.

• Provides tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.

• Participates in and obtains results of department quality and regulatory audits.

• Specifies and coordinates training, OJT and SOP, for Automation, Engineering and contracted personnel.

• Maintains knowledge of current good manufacturing practices (cGMPs).

Knowledge, Skills & Abilities:

• Strong knowledge of cGMP operations, regulatory, and quality requirements.

• Strong written and oral communication skills.

• Strong knowledge of equipment specification requirements.

• Sets priorities within defined responsibilities with minimal supervision/guidance.

• Ability to review and understand engineering drawings.

• Ability to understand project plans and schedules.

• Working knowledge of word processing, spreadsheet, PowerPoint and database management software.

Education and Experience:

• Associate Compliance Specialist - Requires BA/BS (engineering or scientific related field preferred) and 0-2+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute AAS degree and relevant experience in lieu of BA/BS degree.

• Compliance Specialist - Requires BA/BS (engineering or scientific related field preferred) and 3-5+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute AAS degree and relevant experience in lieu of BA/BS degree.

• Sr Compliance Specialist - Requires BA/BS (engineering or scientific related field preferred) and 5+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute AAS degree and relevant experience in lieu of BA/BS degree.

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, disability status, protected veteran status, or any other characteristic protected by law.
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