QC External Lab Coordinator

Regeneron; United States; Vor Ort; USD 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Health and wellness programs

Fitness centers

Stock for employees at all levels

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to coordinate external testing activities and ensure cGMP compliance.

The role acts as the main liaison between CTLs and internal partners, driving timelines, issue resolution, and data integrity through LIMS and SOPs. The successful candidate will oversee performance metrics, CAPAs, and change controls, while supporting on-time shipment and data receipt from external labs.

Qualifikationen

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related field).
• Experience with cGMP is preferred.
• Occasions where you may be required to be on call during off-hours (weekends/holidays).

Aufgaben

• Serve as the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners, including QC, QA, Regulatory Affairs, Manufacturing, and Supply Chain teams.
• Lead cross-functional meetings with CTLs and internal partners to establish project timelines, discuss technical issues, supervise progress, and drive issue resolution.
• Monitor CTL performance metrics, turnaround times, testing capacity, and schedule adherence; grow risks and implement mitigation plans as appropriate.
• Use a sample tracking system (LIMS) to review sample inventory against samples sent and received by external laboratories to resolve accuracy and maintain sample integrity.
• Coordinate activities between external laboratories and Regeneron SMEs to troubleshoot issues and identify root causes.
• Coordinate on-time shipment of samples to Contract Testing Labs.
• Coordinate receipt and entry of test data from Contract Testing Labs.
• Provide technical support for invalid assays, deviations, OOS/OOT investigations.
• Initiate and complete CAPAs and Change Controls in accordance with site procedures.
• Write new SOPs and update existing SOPs as needed.
• Initiate and handle workflows in the electronic document management system.
• Ensure all work follows regulatory requirements (e.g., cGMP), SOPs, and company policies.
• Proactively identify and implement process improvements and lean initiatives.
• Perform other duties relevant to the position as required.

Kenntnisse

Project coordination

Cross-functional collaboration

Regulatory compliance

GMP knowledge

LIMS

Ausbildung

Bachelor's degree in a scientific field

Tools

LIMS

Jobbeschreibung

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are currently looking to fill a Quality Control (QC) External Lab Coordinator position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QC External Testing Coordinators supports the daily operations of the QC External Testing group in accordance with Standard Operating Procedures (SOPs) and cGMP regulations.

When & where:

Location: Rensselaer, New York, United States
Work model: 1st shift | Monday-Friday | 8:00am-4:30pm

Discover your role:

• Serving as the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners, including QC, QA, Regulatory Affairs, Manufacturing, and Supply Chain teams.
• Leading cross-functional meetings with CTLs and internal partners to establish project timelines, discuss technical issues, supervise progress, and drive issue resolution.
• Monitoring CTL performance metrics, turnaround times, testing capacity, and schedule adherence; growing risks and implementing mitigation plans as appropriate.
• Using a sample tracking system (LIMS) to review sample inventory against samples sent and received by external laboratories to resolve accuracy and to maintain sample integrity.
• Coordinating activities between external laboratories and Regeneron subject matter experts (SMEs) to troubleshoot issues and identify root causes.
• Coordinating on-time shipment of samples to Contract Testing Labs.
• Coordinating receipt and entry of test data from Contract Testing Labs.
• Providing technical support as needed for invalid assays, deviations, OOS/OOT investigations.
• Initiating and completing CAPAs and Change Controls in accordance with site procedures.
• Writing new SOPs and updating existing SOPs as needed.
• Initiating and handling workflows in the electronic document management system.
• Ensuring that all work performed follows required regulatory requirements (e.g. cGMP), company policies, and standard operating procedures (SOPs).
• Proactively identifying and implementing process improvements, lean initiatives.
• Performing other duties relevant to the position as required.

This role requires:

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related field)
• Experience with cGMP is preferred.
• Occasions where you may be required to be on call during off-hours (ex. weekends, holiday breaks) to support critical shipment or entry of results.
• Level is settled based on qualifications relevant to the role.

Benefits

• 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.

We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence cer