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About the Role
The Quality Control (QC) External Testing Coordinator supports the daily operations of the QC External Testing group in accordance with Standard Operating Procedures (SOPs) and cGMP regulations. This role serves as the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners.
Responsibilities
- 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 to maintain sample integrity.
- Coordinate activities between external laboratories and Regeneron subject matter experts (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 as needed 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 that all work performed follows required regulatory requirements (e.g. cGMP), company policies, and standard operating procedures (SOPs).
- Proactively identify and implement process improvements, lean initiatives.
- Perform other duties relevant to the position as required.
Requirements
- Experience with cGMP is preferred.
- May be required to be on call during off-hours (ex. weekends, holiday breaks) to support critical shipment or entry of results.
- Background checks may be conducted in accordance with the laws of the country where the position is based to verify information prior to employment commencement.
Location
- Rensselaer, New York, United States
Work Type
- 1st shift
- Monday-Friday
- 8:00am-4:30pm
- On-site
Experience Level
- Level is settled based on qualifications relevant to the role.
Education Level
- Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related field)
Salary/Compensations
- $25.24 - $39.47 per hour
Benefits
- Health and wellness programs
- Fitness centers
- Stock for employees at all levels
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including its approved therapeutic proteins and those involved in clinical studies.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- 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.
- 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.