Quality Control Stability Coordinator

Company Name

Regeneron

Job Description

We are currently looking for a Quality Control (QC) Stability Coordinator for our QC Team with a 1st shift, Monday-Friday, 8am-4:30pm schedule. We successfully manufacture and tests products for patient safety. The QC Stability Coordinator will be performing a variety of activities to administer the stability program and manage data generated in support of Regeneron’s quality program. They will perform all tasks in support of formal stability studies for Regeneron’s clinical and commercial products to ensure their safety, efficacy, and timely delivery for our patients.

Typical Day Responsibilities

• Coordinates with other departments to identify and request material to be put on stability
• Authors stability protocols and obtains necessary approvals prior to study initiation
• Performs review of analytical data and compiles into a central database
• Identifies out of trend or atypical results and supports ongoing investigations
• Provides stability data necessary for the submission of various regulatory documents
• Reviews stability sections of regulatory submission documents
• Provides stability data to other departments upon request
• Prepares samples for inclusion in stability studies (aliquotting, labeling, distribution to appropriate stability chamber)
• Adds required testing in LIMS per approved stability protocol
• Interacts with outside customers or functional peer groups
• Follows all pertinent regulatory agency requirements
• Participates in required training activities
• Authors stability trend reports, decay rate reports and interim reports and routes for approvals in a timely manner
• Ships samples to contractor facilities for testing as required

This Role Might Be For You If

• Enjoys dynamic day to day work
• Can handle challenging priorities
• Can participate in continuous idea projects in addition to routine work
• Are a critical problem solver and can apply fundamental troubleshooting methods
• Enjoys data gathering and data trending to support Regeneron’s products and investigations
• Willing to wear appropriate PPE to get the job done safely when necessary
• Ability to push and pull weights up to 50 lbs

Requirements

To be considered for the QC Stability Coordinator you must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm. You must have the following: Requires BS/BA in Life Sciences or related field; or equivalent combination of experience and education. Level is determined based on qualifications relevant to the role.

Join Us

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Equal Opportunity Employment

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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Information

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (hourly)

$21.20 - $43.80