Skip to main content

This job has expired

You will need to login before you can apply for a job.

QA Investigation Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Jun 6, 2024

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

We are currently looking to fill a QA Investigation Specialist position. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.

In this role, a typical day might include the following:

  • Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations

  • Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances

  • Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports

  • Communicating findings and recommendations at group meetings

  • Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations

  • Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures

  • Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes

  • Participating in and/or leading cross-functional study teams to get results, support and or author investigations

  • Gathering, trending, and analyzing process related data to drive consistency and timeliness

  • Documenting all training

  • Training new employees on investigative processes and techniques

  • Coordinating and/or leading cross-functional meetings with multiple departments.

This role may be for you if you:

  • Excel in a quality driven organization

  • Have an understanding of biologics manufacturing operations

  • 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 Bachelors degree in Life Sciences, Engineering, or related field and the following minimum amounts of relevant experience for each level:

  • Associate Specialist 0-2 years

  • Specialist 2+ years

  • Senior Specialist 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

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 (annually)

$58,480.40 - $124,300.00

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

FacebookTwitterInstagramYouTube Logo

Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert