The QC External Lab Coordinator will coordinate 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.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Plan, prioritize and coordinate 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.
- Use 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.
- Work as part of a team to ensure that samples are delivered to the laboratories on-time.
- Coordinate the issuance and approval of Quality Agreements with the contract labs. Author Master Service Agreements, as necessary.
- Participate as required by QA in GMP audits to the contract labs.
- Document and communicate discrepancies to appropriate personnel in a timely and efficient manner.
- Ensure that all work carried out is in compliance with the required regulatory standards, conform to company policies and standard operating procedures (SOPs).
- Identify the relevant SME to assist the external laboratories in troubleshooting and identify root cause analysis as needed.
- Provide training to other team members as required.
- Proactively identify and implement process improvements, lean initiatives.
- Perform other duties relevant to the position as required.
To be considered for this opportunity you should ideally hold a BSc in relevant discipline. Will substitute education in lieu of experience.
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.