Quality Compliance Coordinator (Product Quality)

Rensselaer, NY, United States
Jan 09, 2021
Required Education
Bachelors Degree
Position Type
Full time
We are currently looking to fill a Quality Compliance Coordinator (Product Quality) position. This position supports assurance of timely commercial and clinical product supply through provision of documentation required for product release and support of comprehensive review of product documentation.

In this role, a typical day might include the following:
• Coordinating the receipt of and/or obtaining results from cross-functional responsible parties in a timely manner to ensure continued product supply
• Fostering communication with key stakeholders in order to properly plan and prioritize workloads based on potential impact to clinical study and commercial supply
• Assisting in collecting data and reporting metrics
• Supporting QA project initiatives for a broad range of topics as the Product Quality group evolves
• Reviewing batch records, specifications, SOPs, data and other supporting documentation related to the manufacturing, testing, packaging and labeling processes to assess compliance with the regulatory submissions
• Determining source of any differences or issues found upon review of the documentation
• Identifying and implementing continuous improvement initiatives
• Performing other support responsibilities as requested

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 or equivalent combination of education and experience. 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 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.