Sr Compliance Specialist

Location
Rensselaer, NY, United States
Posted
Mar 08, 2019
Ref
15858BR
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, 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 and procedural compliance for the Rensselaer Tech Ops
Engineering &Automation Department.

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

• Provide support, information, and assistance to individuals, groups and
management with the initiation, authorship, review, submission, and followup/
completion of documents such as Change Controls, EOE's, NOE's, DNF's, risk
assessments, impact statements and corrective/prevention action plans.
Participate/lead/author investigations and root cause analysis for department
issues ofnon-compliance.

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

• Participate in authorship of responses, and track/trend results of department
quality and regulatory audits/inspections.

• Maintain knowledge of current good manufacturing practices (cGMPs),
Biotech/Pharmaceutical industry guidance/emerging draft guides, etc. and
conduct department relevant evaluations against these documents.

• Identify opportunities for continuous improvement of compliance and lead
improvement initiatives.

• Provide periodic review 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. Instruct/council department members in
proper execution.

• Facilitate reviews and revisions of Department related SOP's, life cycle
documents, plans and policies for each group within the Department.
Knowledge, Skills, and Abilities:

• Current knowledge of cGMP biotech/pharma operations, regulatory and quality
policies, procedures and documentation methods.

• Strong knowledge of Design Lifecycle and Quality Risk Management

• Must work independently and have project management capabilities.

• Knowledge of biotech/pharma manufacturing process/supporting laboratory
testing and regulatory requirements, related terminology and jargon commonly
used in association with daily operations of a facility and the ability to use the
terminology, in context, when discussing issues or generating documentation.

• Strong leadership capabilities and organizational skills.

• Ability to speak to large groups of people (including senior management and
regulatory agencies).

• Excellent writing, communication and interpersonal skills.

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

.Education and Experience:

• Assoc Specialist: Requires BA/BS (engineering, scientific or related field
preferred) and 0-2 years of related experience working in a cGMP environment or
in the operation of a relevant industrial facility; or equivalent combination of
education and experience

• Specialist: Requires BA/BS (engineering, scientific or related field preferred) and
2+ years of related experience working in a cGMP environment or in the
operation of a relevant industrial facility; or equivalent combination of education
and experience
Sr Specialist: Requires BA/BS (engineering, scientific or related field preferred)
and 5+ years of related experience working in a cGMP environment or in the
operation of a relevant industrial facility; or equivalent combination of education
and experience

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.