Job Description
We are currently looking to fill a Sr. Quality Compliance Specialist (Material & Supplier Quality) position. This position maintains site compliance of operations including, Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. Acts as an advisor to these groups of how to maintain compliance. Becomes involved as required to meet schedules or resolve problems.
In this role, a typical day might include the following:
Responsible for ensuring aspects of Quality Compliance for the manufacturing site including manufacturing, quality systems, quality control, validation, facilities, and materials management
Responsible for review and approval of the following types of documents, relating to area functions:
- executed records
- failure investigations
- change control documents
- corrective/preventative action documents
- standard operating procedures
- validation protocols and summary reportsActively participate in continuous improvement initiatives
Interprets compliance requirements for incorporation into company systems/procedures
Participates in regulatory and customer audits
Identify gaps in systems and develop feasible plans for correction
Prepare written reports to management on findings and is integral in the process of developing corrective and preventative actions associated with findings
Reviews and Approves Supplier Corrective Action Requests (SCAR)
Supports the investigation and resolution of deviations related to Material & Supplier Quality
Training of personnel on quality system processes
This role may be for you if you:
Excel in a quality driven organization
Have supplier quality experience
Are organized and have an attention to detail
Can prioritize multiple assignments and changing priorities
Are able to learn and utilize computerized systems for daily performance of tasks
To be considered for this role you must hold a Bachelor’s degree in a related field and the following years' of experience related to the role.
Sr. Quality Compliance Specialist: 5+ years experience
Equivalent combination of education and experience may be considered.
#REGNQA
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.
Salary Range (annually)