Quality Control External Lab Coordinator

Regeneron is looking to hire a QC External Lab Coordinator for a Monday-Friday, 8am-4:30pm schedule! This position is responsible for coordinating sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques to support raw material, utilities, in-process, bulk drug substance and drug product manufacture in a cGMP regulatory environment.

As a QC External Lab Coordinator, a typical day may include the following:

• Uses a sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to determine accuracy and to maintain sample integrity.

• Works as part of a team to ensure that samples are delivered to the laboratories on-time.

• Coordinates the issuance and approval of Quality Agreements with the contract labs.

• Authors Master Service Agreements, as necessary.

• Participates as required by QA in GMP audits to the contract labs.

• Documents and communicates discrepancies to appropriate personnel in a timely and efficient manner.

• Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).

• Reviews and approves method transfer validation protocols and reports.

• Coordinates the external laboratories and Regeneron subject matter experts (SMEs) in troubleshooting and identifying root cause analysis and providing technical advice as needed in support of invalid assays, deviations, OOS/OOT investigations.

• Initiates and completes CAPAs and Change Controls in accordance with site procedures.

• Writes new, and updates current, SOPs as needed.

• Proactively identifies and implements process improvements, lean initiatives.

• Performs other duties relevant to the position as required.

This role might be for you if

• You have strong attention to detail

• Good interpersonal communication skills

• Perform successfully in a collaborative, fast moving environment

To be considered for the QC External Lab Coordinator position you must be willing and able to work Monday-Friday, 8am-4:30pm. This position requires a BS/BA in Biology, Chemistry, Microbiology or related field. Level will be determined by experience related 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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (hourly)

$20.77 - $42.93