In this role you will be responsible for providing QA oversight and support to manufacturing activities. Performs and leads activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
As a Senior QA Specialist a typical day might include, but is not limited to, the following:
Providing QA oversight & support to manufacturing activities within the manufacturing areas to support:
Issuing resolution in conjunction with key stakeholders, including:
Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions
Triage of potential non-conformances including securing necessary documentation for investigation team in real-time
Supporting of/counter signing annotations
Performing area walkthroughs
Providing oversight and review of documentation for non-routine work such as Area in PAAS, Incursions, Changeover
Supporting Inspection readiness
Supporting SOP/Manufacturing Record review for usability and fitness for use
Participating in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities
Performing and leading consultation or advice in alignment with QA policies
Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
Representing the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaising with external partners and providing input on regulatory communications
Training and/or mentoring employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization
Performing activities associated with disposition of product (e.g., manufacturing record review, document review, etc.)
Reviewing, editing, or approving Regeneron controlled documents
Reviewing and approving investigations associated with product or processes
Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
This role might be for you if:
You demonstrate an understanding of biologics manufacturing operations
You have good organizational skills and attention to detail
You have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally
You possess the ability to prioritise multiple assignments and changing priorities and meet deadlines
You possess theability to learn and utilize computerized systems for daily performance of tasks
To be considered for this opportunity you should have a BS/BA in a scientific discipline or related field and minimum 5+ years relevant experience. Relevant experience may be substituted for education requirement.
#LI-Onsite #IREADV #JOBSIEPR #REGNIEQA
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.