The QA Material & Supplier Specialist - Qualification implements activities within the material qualification program to support the utilization of raw materials in Drug Substance and Drug Product Manufacturing.
In this role, a typical day might include the following:
Performing activities associated with qualification of raw materials such as, development of sampling and testing protocols, review of test data, drafting summary reports, etc.; execution of sampling activities may be on the floor
Providing oversight for Drug Product Component Suppliers and the materials provided
Representing Quality Assurance in support of deviations, change controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
Provides guidance internally and externally to ensure quality and regulatory expectations are met in relation to material quality standards
Support and/or approval of SCARs (Supplier Corrective Action Requests)
Working with Suppliers to obtain documentation to support closure of SCARFs (Supplier Corrective Action Request Follow-Ups)
Reviews/approves Drug Product Component Supplier-specific documentation such as Approved Supplier Approvals and TSE/BSE Assessments
Provides support to relevant departments in the utilization of Drug Product Test Components
Establishing, reviewing, and editing Regeneron controlled documents
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement; identify gaps in systems and develop feasible plans for correction.
This role may be for you if you:
Excel in a quality driven organization
Organized individual with attention to detail
Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross functionally
Ability to navigate changing priorities
Ability to learn and use computerized systems for daily performance of tasks
Ability to prioritize, manage multiple tasks, and meet deadlines
Are able to lift up to 25 lbs
Are comfortable working in a warehouse environment 20% of the time
To be considered for this role you must hold a Bachelor’s degree and the following minimum amounts of relevant experience for each level:
Assoc. QA Material Supplier Specialist - 0-2 years
QA Material Supplier Specialist – 3+ years
Senior QA Material Supplier Specialist – 5+ years
May substitute proven experience for education requirement. 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 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.
Salary Range (annually)