Quality Compliance Specialist, Change Control

Regeneron Pharmaceuticals, Inc.; New York (NY); Presencial; USD 62.000 - 129.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. is seeking a Quality Compliance Specialist, Change Control to support our Fill Finish facility in the Rensselaer, NY area. The role ensures cGMP quality and regulatory compliance for change control activities and provides guidance to proposal owners.

Responsibilities include reviewing and approving change control docs, facilitating cross-functional meetings, and driving continuous improvements to the Change Control system. On-site role with standard weekday hours.

Qualificações

• Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory and SOP requirements.
• Facilitate cross-functional meetings and provide guidance to change proposal owners.
• Develop relationships with end users and advise on best practices in Change Control.
• Partner with QA and end users to identify, develop and implement improvements to the Change Control system and procedures.
• Interpret compliance and regulatory requirements for incorporation into departmental systems and documentation.

Responsabilidades

• 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.

Conhecimentos

Quality compliance

Change control

Regulatory

Formação

Bachelor's degree in a scientific or engineering discipline

Descrição da vaga

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Compliance Specialist, Change Control to support our Fill Finish facility. In this role, the Quality 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.

When & where:
Location: Rensselaer, New York, United States
Work model: Monday-Friday, 8:00 AM - 4:30 PM

Discover your role:

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.

This role requires:

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+ Years

Senior Specialist: 6+ years

Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you?

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $62,355.00 - $128,700.00