Biotech Production Compliance Coordinator

Location
Rensselaer, New York, United States of America
Posted
Jul 04, 2021
Ref
24925BR
Required Education
Bachelors Degree
Position Type
Full time
Summary: Performs all compliance related administrative tasks necessary for supporting commercial manufacturing operations.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Independently prepares all compliance documentation required to implement corrective actions and changes to various GMP processes in support of manufacturing operations, and in accordance with cGMP standards and written procedures
• Analyzes and evaluates information gathered through cross functional interactions and presents findings and recommendations at group meetings
• Reviews completed batch records and logbooks in accordance with cGMP standards to ensure compliance with written procedure
• 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 support investigations and author change controls
• Gathers, trends, and analyzes process related data to drive consistency and timeliness
• Documents all training
• Assists with training of new employees
• Ensures all tasks are performed in a manner consistent with safety standardsEducation and Experience:
Level II: Bachelor's degree, preferably in Life Sciences or a related field, or
AS/AAS Degree in Biotechnology/Biological Science and 0-2 years of relevant work experience
Level III: Requires BS/BA in Life Sciences, or related field and 2 years of
relevant experience or equivalent combination of education and experience
Sr Level: Requires BS/BA in Life Sciences, or related field and 5 years of
relevant experience or equivalent combination of education and experience
Title level is based on education and experience

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.