This role involves performing and leading activities in support of a cross functional team of Manufacturing and MES Operations by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. The successful candidate will continuously provide QA input and feedback in accordance with cGMPs, and Regeneron’s policies and procedures.
As a SR QA Specialist a typical day might include, but is not limited to, the following:
Support/lead efforts to further deploy MES across the plant
Support sustainability initiatives and change management of effective MES records to Change Control and CAPA timelines
Development and delivery of MES training materials for QA MES users
Collaborating in the creation, review, and approval of MES recipes, record design and record testing documentation
Providing end-user support for MES usage within QA and working closely with IT to troubleshoot problems associated with QA functions within MES
Perform assessments of existing procedures/documents for MES impact
Create, review, and approve related SOPs and other Regeneron controlled documents
Support audits, inspections and investigations
Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
Represent the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications
Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Provide consultation or advice in alignment with QA policies
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Support inspection readiness and participate in regulatory, customer and internal inspections
This role might be for you if you have:
An 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
An ability to handle multiple assignments and changing priorities
An ability to learn and utilize computerized systems for daily performance of tasks
An ability to prioritize, manage multiple tasks, and meet deadlines
To be considered for this opportunity you should have a BS/BA in scientific discipline or related field. 5+ years experience is required for Specialist level. Relevant experience may be substituted for education requirement. Experience in Manufacturing Execution Systems is preferable.
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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.