Quality Control Specialist
About the role
This position is a Monday-Friday 8am-4:30pm schedule. This position will be supporting project management of validation and qualification activities, transfer to partner and contract sites, and life cycle management of assays utilized in Quality Control testing.
Responsibilities
- Project manage validation and qualification activities within the QC TR Chemistry group
- Collaborate with internal and external teams to coordinate project management activities
- Write and revise assay transfer protocols to external partners and contract labs
- Write and revise control test procedures and SOPs
- Coincide and participate in weekly project update meetings
- Communicate to management any delay in validation/transfer timelines
- Communicate method updates to partners and manage progress of updates
- Coincide post-transfer investigations between contract sites and collaborative partners
- Raise discrepancies to management, as needed.
Requirements
- BS/BA in Chemistry, Biochemistry, Biology, or related field, with 2+ years of experience
- Experience with project management and experience in a GMP setting is preferred
Qualifications
To be considered for the QC Technical Resources Specialist position you must have a BS/BA in Chemistry, Biochemistry, Biology, or related field, with 2+ years of experience. Experience with project management and experience in a GMP setting is preferred.
Skills
Enjoy working in a fast-paced environment
Are able to multi-task, prioritize and execute projects independently
Are able to write and review transfer documents such as protocols and reports
Enjoy and are able to communicate cross-functionally to business units
Can take on new and sometimes ambiguous challenges and learn quickly
Develop and drive scientific and/or business-related improvement ideas
Possess effective time management skills, and the drive to meet deadlines
Have working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Benefits
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.
Pay
Salary Range (annually): $67,400.00 - $110,000.00
Schedule
Monday-Friday 8am-4:30pm