Quality Systems Specialist
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, NY, United States
- Start date
- Jan 8, 2021
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- Discipline
- Clinical, Clinical Medicine, Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
As a Quality Systems Specialist, a typical day might include the following:
- Developing and leading training for end users
- Partnering with other members of the Quality Assurance team and/or end users to identify, develop, and implement continuous improvements
- Work with end users in understanding business needs and crafting creative solutions.
- Developing, monitoring, and communicating metrics to ensure the health of the Change Control System
- Assisting as needed in audits and inspections
- Reviewing and approving of Change Proposals as required
- Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory
- Proven track record to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven record of shifting thought processes quickly from one task to another.
- Aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment
- Consistent record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan
- Possess excellent interpersonal, written and oral communication skills
- Ability to utilize active listening skills to understand concerns or reasoning in order to build strategic relationships
- Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.
Company
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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