Quality Control Analyst - Reference Standards
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- East Greenbush, New York
- Start date
- Aug 7, 2024
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- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
We are looking to fill a Quality Control Analyst position with a Monday-Friday, 8am-4:30pm schedule.
As a QC Analyst, a typical day might include the following:
- Responsible for QC Reference Standard and Materials processes, including qualification, re-qualification, implementation, and stability monitoring of product reference standards and qualified materials used in QC testing.
- Set and maintain internal requirements for product reference standards.
- Ensure timely procurement and implementation of product reference standards and qualified materials.
- Own and complete Change Controls to support QC Materials processes (often several at once).
- Provide program and lifecycle management for product reference standards and qualified materials.
- Create and revise high-level documentation, including Technical Documents, Standard Operating Procedures (SOPs), Certificates of Qualification, Primary Qualification Reports, and Biologics License Applications (BLA).
- Serve as a representative for the QC Materials team in cross-functional meetings.
- Be responsible for and maintain appropriate inventory levels of product reference standards and qualified materials.
- Work with members of QC Labs, Tarrytown, and Business Partners for reagent and product reference standard forecasts.
- Support sub-aliquotting, shipping, inventory, and handling of reference standards and qualified materials.
- Provide excellent customer service to partners and laboratories.
- Evaluate, document, and support investigation of deviations in the appropriate Quality System.
- Demonstrate outstanding time management, prioritization, written and oral communication, presentation, and organization skills.
- Prepare and provide regular data updates and deliverables to management and group.
- Lead and coordinate the improvement effort of streamlining processes.
- Adhere to cGMP policies, procedures, and training.
This role might be for you if:
- You have a strong attention to detail
- You have good interdepartmental communication skills
- You can multi-task on several projects simultaneously
To be considered for the QC Analyst position you must be willing and able to work a Monday-Friday 8am-4:30pm schedule. Various levels require the following:
- Associate QC Analyst: BS/BA in Life Sciences, or related field, or an equivalent combination of education and experience.
- QC Analyst: BS/BA in Life Sciences, or related field, and a minimum of 12-18+ months of related experience; or an equivalent combination of education and experience.
- Sr. QC Analyst I: BS/BA in Life Sciences, or related field, and 4+ years of experience; or an equivalent combination of education and experience.
- Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (hourly)
$21.01 - $37.79Company
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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