QA Investigation Specialist
- Regeneron Pharmaceuticals, Inc.
- Rensselaer, New York
- Start date
- Mar 24, 2023
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
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 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.
#REGNQADoes 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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)$55,700.00 - $121,300.00
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
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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