Quality Assurance Compliance Specialist, Control

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Compliance Specialist, Change Control to support our Fill Finish facility. In this role, the Quality Assurance Compliance Specialist ensures quality and compliance to cGMP’s, internal, external, and international requirements with respect to changing control activities. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Location:
  
  Rensselaer, New York, United States
• Work model:
  Monday-Friday, 8:00 AM - 5:00 PM

• As a Quality Compliance Specialist (Change Control), a typical day might include the following:
• Reviewing, assessing, editing, and approving change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Facilitating cross functional meetings and providing guidance and consultation to change proposal owners
• Developing relationships with end users and providing advice on best practices in Change Control
• Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures
• Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.
• Supporting regulatory and customer audits.

• Experience in change control function is strongly preferred.

• Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory.
• Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
• Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment.
• Proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure or plan.
• Possess excellent interpersonal, written and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships.
• Proficient digital literacy in Microsoft (MS) Word, Excel and PowerPoint required. Experience with Process Compliance/QUMAS heavily preferred.

Bachelors in a scientific or engineering discipline or related field with the following minimum amounts of relevant experience for each level, in a combination of quality, production, engineering, regulatory (chemistry, manufacturing and control) and/or laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.

• Associate Specialist – 0-2+ years
• Specialist – 2-5+ years
• Senior Specialist – 5+ years

Level is determined based on qualifications relevant to the role.

$67,400.00 - $

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…