Quality Control Extractable and Leachable Specialist

Rensselaer, NY, United States
Feb 18, 2021
Required Education
Bachelors Degree
Position Type
Full time
Regeneron is currently looking for a Quality Control (QC) Extractable & Leachable Specialist with a Monday-Friday, 8am-4:30pm schedule to join our Analytical Sciences team. As a subject matter expert in extractables and leachables (EL), a QC EL Specialist supports the Manufacturing, Process Sciences (PS), and QC departments by providing resource and timeline management for EL studies, and performing study design and documentation that supports EL program and business goals.

As a QC Extractable& Leachable Specialist, a typical day might include the following:
• Manages projects and timelines to ensure deliverables meeting deadlines.
• Represents EL programs in cross functional meetings, builds and maintains relationships with stakeholders through program lifecycle.
• Facilitates testing of leachable studies by establishing and maintaining processes for sample chain of custody, storage, and disposal.
• Maintains awareness and thorough understanding of current regulations to ensure EL program is compliant and maintains a state-of-the-art EL program.
• Authors and reviews technical justifications, study protocols and reports, and other controlled documents (e.g., SOPs, WIs, JAs, and Forms).
• Performs EL risk assessment for single use components in manufacturing process.
• Performs impact assessment for change notifications and change controls related to EL process; contributes to risk assessment process and implement actions as needed.
• Formulates continuous improvement initiatives and executes special projects to enhance EL programs in terms of testing efficiency and overall program performance.

This role might be for you if:
• You can take a proactive and self-disciplined approach to prioritize projects to meet established goals.
• You thrive in a fast-paced setting where your priorities can quickly change based on the needs of the business and our patients.
• You handle issues appropriately with excellent communication skills (including inter-person, oral presentation, and writing skills).
• You enjoy the challenge to adjust strategies based on new situations and appreciate a culture where continuous improvement is not just a metric, rather a mindset for everyone to get better every day.

To be considered for the QC Extractable& Leachable Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BA/BS in chemistry, biology or related field with 3+ years of related experience. Previous experience in analytical testing and method development or equivalent extractable and leachable experience is preferred. Prior laboratory experience is preferred. Level is determined based on qualifications relevant 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 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.