Lead Investigation Specialist (MSM)

Rensselaer, NY, United States
Mar 30, 2021
Required Education
Position Type
Full time
Summary: Performs all compliance related tasks necessary to complete investigations and implementation of robust corrective actions for supporting manufacturing operations. Will manage a small team of Investigation Specialists.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Independently investigates non comformances and preventing reocurrences in support of manufacturing operations.
• Prepares 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 findings and recommendations at group meetings
• Reviews completed batch records and logbooks 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 to obtain necessary data in support of investigations and track effectiveness of changes.
• Participates in/and/or leads cross-functional study teams to drive 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.

Education and Experience:
• BS/BA required in Life Sciences, Engineering, or related field or comparable related work experience appropriate for the level as follows:

o 0-2 years for Associate Specialist

o 2-5 years for Specialist

o 5+ years for Sr. Specialist
• Relevent experience in biotech, scientific or pharmaceutical industry experience may be substituted in lieu of educational requirement.

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.