Job Description
Summary: Determines disposition of raw materials and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
As Sr QA Specialist within the Raw Materials department a typical day may include:
Reviews release data, prepares appropriate release documentation and complete release of vendor raw materials.
Performs AQL visual inspections.
Manages QA requirements of SCAR process i.e. initiation, review and monitoring
Supports Supplier Quality
Supports Materials Management
Initiates, edits, review and approves change control and SOPs.
Provide training as required within the QA Raw Materials Group
Performs compliance monitoring of area operations and notifies area and Quality Management of any observed non-compliance.
Participates in regulatory and customer audits
The successful candidate may be required to work extended day shift
Education and Experience:
Requires BS/BA in Life sciences/Engineering or related field. May consider another degree discipline with relevant experience; cGMP experience is desirable.
5+ years experience for Sr Specialist level
#REGNIEQA #JOBSIEPR #IRELIM #LI-Onsite
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.