Compliance Specialist (Warehouse & Logistics)

Rensselaer, New York
May 01, 2018
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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: Leads compliance related activities, such as investigations, change controls, CAPA, etc. across all areas within the Warehouse & Logistics department.

Essential Duties and Responsibilities include, but are not limited to, the following:
• 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.
• Leads and participates directly in the investigation process.
• Writes and/or reviews investigation reports.
• Ensures Corrective & Preventative Actions are appropriate, are implemented as planned and have the intended effectiveness.
• Identifies recurring events and ensures appropriate actions are taken, such as Management notification.
• Keeps team members informed of the status of assigned work.
• Leads and manages Change Controls for Warehouse & Logistics.
• Works with the team to develop robust training programs.
• Provides coordination support during regulatory inspections and partner audits.
• Participates in inspection readiness activities.
• Writes and edits Warehouse & Logistics standard operating procedures ensuring all documents are in compliance with regulatory requirements.
• May inform management of non-conformance trends and regulatory requirement changes.
• May ensure Warehouse & Logistics quality events (i.e. change controls, investigations, and CAPAs) are addressed in a timely manner.
• May participate in risk assessment and failure mode and effects analysis (FMEA) activities.

Knowledge, Skills, and Abilities:
• Proficient in Microsoft Office programs.
Education and Experience:
• Assoc. Specialist: Bachelor's degree in a related field with 0-2 years' relevant experience; or equivalent combination of education and experience.
• Specialist: Bachelor's degree in a related field with 2+ years' relevant experience including experience in leading investigations/change controls in a cGMP environment; 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.

Requisition Number: 13256BR