Quality Compliance Specialist; Controls

Overview

Regeneron is currently looking for a Quality Compliance Specialist with a 1st shift, Monday-Friday, 8am-4:30pm schedule. This position will focus on internal change controls. The Quality Compliance Specialist ensures quality and compliance to cGMPs, internal, external, and international requirements with respect to change control activities.

• 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 control owners.
• Developing relationships with end users and providing guidance on standard processes 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.

• 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 a cGMP 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 Word, Excel and PowerPoint required. Experience with Veeva/QMS preferred.

• Must be willing and able to work Monday-Friday, 8am-4:30pm.
• Education:
  
  B.S. in Life Sciences, Engineering or related field.
• Levels:
  Associate Quality Compliance Specialist (0-2+ years), Quality Compliance Specialist (2-5+ years), Senior Quality Compliance Specialist (5+ years).
• May substitute proven experience for education requirement. Experience in change control function strongly preferred. Level is determined based on qualifications relevant to the role.

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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

Salary Range (annually)

$62,355.00 - $

To Regeneron’s on-site policy and expectations for your role and location, speak with your recruiter. Regeneron’s benefits vary by location and may include health and wellness programs, 401(k) company match, paid time off, and other programs. For more information about Regeneron benefits in the US, candidates may discuss with their recruiter.