Biotech Production Compliance Coordinator

Location
Rensselaer, NY, United States
Posted
Aug 30, 2020
Ref
20903BR
Required Education
Bachelors Degree
Position Type
Full time
Summary:

Performs all compliance related administrative tasks necessary for supporting commercial manufacturing operations.

Level to be determined based on qualifications relevant to the role.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Performs administrative tasks in all areas of production as needed in accordance with cGMP standards and in compliance with written procedures.
• 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 cross-functional study teams to support and/or author investigations.
• 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 standards.

Requirements:
• Bachelor's degree, preferably in Life Sciences or a related field, or
• AS/AAS Degree in Biotechnology/Biological Science and 2 years of relevant work experience.
• Relevant biotech or pharmaceutical industry experience may be substituted in lieu of educational requirement.
• Ability to maintain integrity and honesty at all times
• Ability to work independently and as part of a team
• Ability to communicate with transparency
• Continuously drive to improve processes for improved performance
• Demonstrate respectful behavior at all times
• Ability to learn and follow routine procedures independently
• Basic troubleshooting skills
• Identify and communicate continuous improvement ideas
• Ability to work in an every-changing environment
• Build and maintain working relationships
• Ability to gather, generate, and interpret data

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.