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Compliance Specialist - QC (Stability)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, NY, United States
Start date
Sep 22, 2020

View more

Discipline
Clinical, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

We are currently looking to fill a Compliance Specialist - QC. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Compliance Specialist - QC assist Quality Control laboratories with investigations, deviations, method changes and document workflows as needed by specific functions including Chemistry, Bioassay, Microbiology and Virology.

As a Compliance Specialist a typical day might include the following:
• Ensuring 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.
• Leading and participating directly in the investigation process.
• Assisting in the execution of Corrective & Preventative Actions and ensuring they are appropriate, effective, and are implemented as planned in a timely manner.
• Identifying recurring events and trends within Quality Control's deviations and proposing continuous improvement ideas based on findings.
• Keeping team members informed of the status of assigned work.
This role might be for you if:
• Experienced in writing and/or reviewing investigation reports.
• Excel at contributing in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions.
• Excellent time management, organizational skills and written and verbal communication.

To be considered for the Compliance Specialist - QC you must have the following; at Associate Specialist level a Bachelor's in chemistry, biology or a related field, Specialist level Bachelor's in chemistry, biology or related field with 2 years of experience in quality control/analytical sciences including a minimum of 1 year of experience leading lab investigations in a cGMP environment. Senior Specialist level requires Bachelor's in chemistry, biology or related field with 5 years of experience in quality control/analytical sciences including a minimum of 1 year of experience leading lab investigations in a cGMP environment. An equivalent combination of education and experience is also considered. Level is 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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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