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.
The successful candidate will be required to work shift which includes a mix of days & nights
As a QA Specialist a typical shift might include, but is not limited to, the following:
Provides QA oversight & support to manufacturing activities within the manufacturing areas to support:
Issue 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
Support of/counter signing annotations
Perform area walkthroughs
Provide oversight and review of documentation for non-routine work such as Area in PAAS, Incursions, Changeover
Support Inspection readiness
Support SOP/Manufacturing Record review for usability and fitness for use
Participate in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities
Perform and lead consultation or advice in alignment with QA policies
Represent Quality Assurance in support of complex and/or significant 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; 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
Perform activities associated with disposition of product (e.g., manufacturing record review, document review, etc.)
Review, edit, or approve Regeneron controlled documents
Review and approve 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
Good organizational skills and attention to detail
Good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally
The ability to prioritise multiple assignments and changing priorities and meet deadlines
An ability 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.
Associate QA Specialist level - minimum 0-2 years relevant experience.
QA Specialist level - minimum 3-5 years relevant experience.
Sr QA Specialist level - 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.