Compliance Specialist (Packaging and Labeling)

Location
Rensselaer, NY, United States
Posted
Nov 11, 2020
Ref
20926BR
Required Education
Bachelors Degree
Position Type
Full time
Summary: The Compliance Specialist, Drug Product Manufacturing is a member of the Drug Product Manufacturing Team and is responsible for operations support and compliance related activities for the manufacture of Regeneron products.

Level to be determined based on qualifications relevant to the role

Essential Duties and Responsibilities include, but are not limited to, the following:
• Lead and manage deviation investigations, CAPAs, and change controls.
• Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
• Responsible for generating and tracking performance metrics.
• Maintains knowledge of current good manufacturing practices cGMPs.
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
• Travel to contract manufacturers or business partners, as required (25% or less)
• Maintain required training status on Regeneron specific work instructions and SOP's.
• Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
• Continuous Process Improvement Implementation.
• May require supervisory responsibilities.

Knowledge, skills, and abilities:
• Knowledge of drug product manufacturing from formulation through the final package.
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.
• Strong interpersonal, written and oral communication skills.
• Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
• Shows resiliency and flexibility in the face of challenges and adversarial situations.
• Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
• Experience in collaborating with CMOs/CROs is preferred.
• Fluent in English with a preference given to candidates with competencies in German and/or French (oral and written).

Education and Experience:
• Associate Specialist; minimum of BS/BA in scientific discipline with 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).
• Specialist; minimum of BS/BA in scientific discipline with 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).
• Senior Specialist; minimum of BS/BA in scientific discipline with 5+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products).

Level to be 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.
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