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Sr. Quality Compliance Specialist

Company Name:
Regeneron
Summary:
Regeneron is currently seeking a talented and motivated Quality Compliance Specialist to join our QA department reporting to the Sr. Manager of Quality Systems. The position functions as a direct counterpart to manufacturing operation functions to provide day-to-day QA support. The candidate will serve as the QA point-of-contact for their assigned operational area and will be primarily responsible for QA review and approval of deviations, CAPAs, extension records, and document revisions.
Essential Functions:
Investigation review and approval.
Collaboration on determining appropriate CAPAs to mitigate root cause.
Meet schedules and due dates.
Support regulatory and customer audits.
Additional responsibilities assigned by manager which may include assistance with process transfers to CMOs, review of CMO deviations, maintenance of quality agreements, etc..
Required Skills:
Problem solving methodologies such as (KT investigation model, Root Cause Analysis (RCA), Hazard Analysis and Critical Control Point (HACCP) etc.).
Strong interpersonal, written and oral communication skills.
A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
Knowledge of MS word, Excel, database management and statistical analysis.
Effectively organize and manage work responsibilities of self independently. Time and project management skills with the ability to multi-task are essential.
Experience with documentation and quality systems.
Knowledge of pharmaceutical/biotechnology process so as to be able to make appropriate decisions.
Ability to communicate effectively, both written and verbal.
Experience and Required Skills: Education and Experience:
Requires BS/BA in scientific discipline or related field with 5+ years of related work experience in pharmaceutical or related industry. Previous experience and knowledge of deviation management practices preferred.
Certified Quality Professional or Certified Quality Engineer (a plus).
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.

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