We are currently looking to fill a Quality Compliance Specialist (Change Control). Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC Specialist ensures quality and compliance to cGMPs, internal, external and international requirements with respect to change control activities.
As a Quality Compliance Specialist, 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
•Mentoring and training others on change control tools and processes and evaluating change control processes and tools to drive continuous improvement.
•Monitoring and communicating metrics and trend reports to management for the Change Control system.
•Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures and documentation.
•Supporting regulatory and customer audits.
•Leading Change Control Committee meetings and acting as point of contact for notification of partner change notices and inter-company change control related communication.
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.
•Aptitude 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 utilize 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.
To be considered for the Quality Compliance Specialist position you must have a Bachelor's 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.
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