Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Summary: The position functions to provide day-to-day QA support and ensure quality systems are executed appropriately according to current requirements. The candidate will serve as the QA point-of-contact for their assigned operational area and will be primarily responsible for approving deviation investigation records, assigning CAPAs, and performing documentation review.
Essential Duties and Responsibilities include, but are not limited to, the following:
Investigation review and approval
Collaboration on determining appropriate CAPAs to mitigate root cause
CAPA record allocation/assignment for QA review
Facilitation and/or coordination of daily deviation review meeting
Monitor record activity and due dates
Meet schedules and due dates
Support regulatory and customer audits
Additional responsibilities assigned by manager which may include assistance with process transfers to CMO's, review of CMO deviations, maintenance of quality agreements, etc.
Knowledge, Skills and Abilities:
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.
Education and Experience:
Associate Specialist level - Requires BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry.
Specialist level - Requires BS/BA in scientific discipline or related field with 4+ years of relevant work experience in pharmaceutical or related industry.
Senior Specialist level - Requires BS/BA in scientific discipline or related field with 6+ years of relevant work experience in pharmaceutical or related industry.
Previous experience and knowledge of deviation management practices preferred.
Relevant experience may be considered in lieu of educational requirement.
*Level will be determined based on skills and related experience.*
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 Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Associated topics: prevent, prevention, qa, quality, quality assurance, quality assurance analyst, software quality assurance, software quality engineer, test engineer, tester