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QA Investigation Specialist (Fill Finish)

Job Description

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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.


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 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)

$58,480.40 - $124,300.00