Quality Compliance Specialist (Change Control Partner Relations)
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Troy, New York
- Start date
- May 31, 2023
View more
- Discipline
- Clinical, Clinical Medicine, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
We are currently looking to fill a Quality Compliance Specialist 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
Actively 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
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 BS/BA in a related field and the following amount of relevant experience for each level:
Associate Quality Compliance Specialist - 1-3 years
Quality Compliance Specialist- 3-5 years
Sr. Quality Compliance Specialist - 8+ years
Experience may be substituted in lieu of education. Level is determined based on qualifications relevant to the specific role.
#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)
$55,700.00 - $121,300.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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