We are looking to hire a Senior QA Specialist, focusing on our Commercial Pack and Label area. This role performs activities in support of dispositions product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
A typical day could include:
Knowledge, skills, and abilities:
- Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; collaborate closely with external partners and provide input on regulatory communications
- 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
- Participate in investigations associated with raw materials or product
- Perform status labeling of raw materials and product
- Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Education and Experience:
- Understanding of biologics manufacturing operations is preferred
- Good organizational skills and attention to detail
- Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Ability to handle multiple assignments and changing priorities.
- Ability to learn and apply computerized systems for daily performance of tasks
- Ability to prioritize, manage multiple tasks, and meet timelines
- Ability to stand for periods of time when performing tasks on the floor.
- Associate level - Requires BS/BA in scientific subject area or related field and minimum 2 years relevant experience. Relevant experience may be substituted for education requirement.
- Mid level - Requires BS/BA in scientific subject area or related field and minimum 4 years relevant experience. Relevant experience may be substituted for education requirement.
- Senior level - Requires BS/BA in scientific subject area or related field and minimum 6 years relevant experience. Relevant experience may be substituted for education requirement.
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.
This job has expired.