Quality Assurance Compliance Specialist, Change Control

Regeneron Pharmaceuticals Inc.; New York (NY); On-site; USD 67,000 - 110,000; Full time

Benefits offered by this job

Health and wellness programs

Stock for employees

Fitness centers

Job summary

Regeneron Pharmaceuticals Inc. in Rensselaer, NY is seeking a Quality Assurance Compliance Specialist, Change Control to support our Fill Finish facility.

This role ensures quality and compliance with cGMPs, internal SOPs, and international requirements through precise change control activities. You will review, edit, and approve change control documentation; facilitate cross-functional meetings; and advise change owners on best practices.

Qualifications

• Bachelor's in a scientific or engineering discipline with relevant experience in quality, production, regulatory (chemistry, manufacturing and control) and/or laboratory roles.
• Experience implementing cGMP requirements and knowledge of FDA regulations.
• Strong written and verbal communication and ability to work across functions.

Responsibilities

• 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.

Skills

Attention to detail

Scientific judgment

Interpersonal communication

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

MS Word

Excel

PowerPoint

QUMAS

Job description

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 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.

When & where:

Location: Rensselaer, New York, United States

Work model: Monday-Friday, 8:00 AM - 5:00 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 might be for you if:

• 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.

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 - 2-5+ years
• Senior Specialist - 5+ years

Level is determined based on qualifications relevant to the role.

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 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.

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 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.

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.

Salary Range (annually)

$67,400.00 - $110,000.00