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QA Specialist (Deviation Investigation)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, NY, United States
Start date
Sep 4, 2019

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Discipline
Clinical, Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, 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:

• QA Associate - Requires BS/BA in scientific discipline or related field and 0-2 years relevant experience in pharmaceutical or related industry.

• 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, disability status, protected veteran status, or any other characteristic protected by law.
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Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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