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QA Investigation Specialist

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Sep 30, 2022

View more

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

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

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

  • Independently reviews and approves investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations.

  • Coaches investigation team to enable preparation of investigation reports that include recommendations on investigation findings for medium/high severity non-conformances.

  • Analyzes and evaluates information gathered through investigations, summarizes information and trends in investigation reports.

  • Presents quality considerations and recommendations at group meetings.

  • Reviews primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations.

  • Reviews, edits and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.

  • Monitors production processes and quality systems data to acquire vital data in support of investigations and track efficiency of changes.

  • Participates in and/or leads cross-functional study teams to get results, support and or author investigations.

  • Gathers, trends and analyzes process related data to drive consistency and timeliness.

  • Documents all training.

  • Trains new employees on investigative processes and techniques.

  • Coordinates and/or leads 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 Bachelor’s 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.

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.

#REGNQA

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

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