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Quality Compliance Specialist (Change Control)

Job Description

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We are currently looking to fill a Quality Compliance Specialist (Change Control) position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to primarily facilitate activities and relationships regarding change controls and partner notifications.

A typical day might include, but is not limited to, the following:

  • Reviewing and approving Change Proposals as required

  • Facilitating cross functional meetings and providing guidance and consultation to change control owners

  • Meeting with partners to discuss changes for applicable products

  • Maintaining internal databases and tracking of partner notifications

  • Developing, monitoring, and communicating metrics to ensure the health of the partner/change notification process

  • Partnering with counterparts to ensure global alignment of processes, systems, and procedures

  • Partnering with colleagues in other departments on strategies to ensure changes do not impact supply

  • Assisting as needed in audits and inspections

This role might be for you if:

  • You are knowledgeable in Biotech/Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulations

  • You demonstrate the 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

  • You have the aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GMP environment

  • You have a 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

  • You possess excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships

  • You have proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required. Experience with Quality Management Systems heavily preferred

To be considered for this position you must have a Bachelor’s in a scientific or engineering discipline or related field with 3+ years’ experience in a combination of Quality, Production, Engineering, Regulatory (Chemistry, Manufacturing and Control) and/or Laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements. Experience in change control function strongly preferred. Level is determined based on qualifications relevant to the role.

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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.