QA Validation Specialist - Cold Chain/Equipment
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Rensselaer, New York
- Start date
- Dec 2, 2022
View more
- Discipline
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The QA Validation Department at Regeneron is adding to their team! We are currently looking to fill openings in our Equipment/Cold Chain Validation. This team focuses on two main areas supporting the equipment used to create our product, our manufacturing areas and the Cold Chain equipment (Warehouse and Controlled Temperature Units) where drug products and substance, raw materials are stored; a background in thermal dynamics is preferred. This area will validate, qualify and verify equipment, systems, documentation and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
The day to day of a QA Validation Specialist could include, but are not limited to, the following:
- Generating, implementing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
- Analyzing the results of testing and deciding the acceptability of results against pre-determined criteria
- Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements
- Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation
This role might be for you if you:
- Have validation or engineering experience in the pharmaceutical industry or similar industries
- Can coordinate with other departments or outside contractors/vendors to complete validation tasks
- Continuously seek to improve processes for improved performance
- Are looking for a great culture! Regeneron has best-in-class onsite and offsite events throughout the year, onsite cafeterias, company affiliated sports teams and clubs, and a culture centered on diversity and inclusion.
To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences and
- 0 – 2 years of relevant experience for an Associate
- 2+ years of relevant experience for a Specialist
- 5+ years of relevant experience for a Senior Specialist
- May substitute proven experience for education requirement
Salary Range (annually)
$63,500.00 - $103,700.00Company
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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