Job Description:
As a QC External Lab Coordinator, you will perform 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 and bulk drug substance manufacture in a cGMP regulatory environment.
Responsibilities:
* Planning, prioritizing and coordinating sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques
* Using our sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to resolve accuracy and maintain sample integrity
* Working as part of a team to ensure that samples are delivered to the laboratories on-time
* Coordinating the issuance and approval of Quality Agreements with the contract labs
Additional Responsibilities:
* Author Master Service Agreements, as necessary
* Participating as required by QA in GMP audits to the contract labs
* Documenting and communicating discrepancies to appropriate personnel in a timely and efficient manner
* Ensuring that all work carried out is in compliance with the required regulatory standards, conform to company policies and standard operating procedures (SOPs)
* Reviewing and approving method transfer validation protocols and reports
* Assisting the external laboratories in troubleshooting and identify root cause analysis and provide technical advice as needed
* Conducting laboratory investigations and generate reports in response to invalid assays, Deviations, OOS/OOT
* Initiating and completing CAPAs and Change Controls in accordance with site procedures
Requirements:
You must hold a third-level qualification (BSc degree or higher) in biology, chemistry, microbiology or related field with relative experience (preferably in the pharmaceutical or biotechnology industries).
We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, 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.