Compliance Specialist - QC (Stability)

Rensselaer, NY, United States
Sep 22, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.