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QA Specialist
3 months ago
The Quality Assurance, Raw Materials department at Regeneron is adding to their team The QA Specialist - Raw Materials, performs activities in support of disposition product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
**Shift Available**: Weds-Sat, 6am-4:30pm, EST
**In this role, a typical day may include the following**:
Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Train and/or mentor junior employees, including providing insights and education on processes and procedures;
Provides consultation or advice in alignment with QA policies;
Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.). Activities may be on the floor or at a desk
Review, edit, or approve Regeneron controlled documents
Review and approval of investigations associated with raw materials, product, laboratory, facilities, and materials.
Perform status labeling of raw materials and product
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
**This role may be a fit for you if you have**:
Understanding of biologics manufacturing operations
Good organizational skills and attention to detail
Abilitiy to handle multiple assignments and changing priorities
Ability to learn and utilized computerized systems for daily performance of tasks
Ability to stand for periods of time when performing tasks on the floor (Raw Materials)
Ability to lift up to 50 pounds (Raw Materials)
**Associate**: 2+ years
**Specialist**: 4+ years
**Sr. Specialist**: 6+ years
Relevant experience may be substituted for education requirement.
REGNQA
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Salary Range (annually) $58,480.40 - $124,300.00
