Biotech Production Compliance Coordinator

Rensselaer, NY, United States
Jan 06, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Biotech Production Compliance Coordinator position. This position performs all compliance related administrative tasks necessary for supporting commercial manufacturing operations.

In this role, a typical day might include the following:
• Performing administrative tasks in all areas of production as needed in accordance with cGMP standards and in compliance with written procedures
• Reviewing completed batch records and logbooks in accordance with cGMP standards to ensure compliance with written procedure
• 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 obtain necessary data in support of investigations and track effectiveness of changes
• Participating in cross-functional study teams to support and/or author investigations
• Gathering, trending, and analyzing process related data to drive consistency and timeliness
• Documenting all training
• Assisting with training of new employees
• Ensuring all tasks are performed in a manner consistent with safety standards

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, 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. Level to be 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 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.