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QA Specialist (Packaging)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, NY
Start date
Oct 12, 2019

View more

Discipline
Clinical, Quality, Quality Assurance
Required Education
Associate 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: Performs activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

*Level to be determined based on qualifications relevant to the role*

Essential Duties and Responsibilities include, but are not limited to, the following:

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution

• Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications

• Train and/or mentor junior employees, including providing insights and education on processes and procedures

• Provides consultation or advice in alignment with QA policies

• Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc). Activities may be on the floor or at a desk

• Review, edit, or approve Regeneron controlled documents

• Participate in investigations associated with raw materials or product

• Perform status labeling of raw materials and product

• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

Knowledge, skills, and abilities:

• Understanding of biologics manufacturing operations is preferred

• Good organizational skills and attention to detail

• Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.

• Ability to handle multiple assignments and changing priorities.

• Ability to learn and utilize computerized systems for daily performance of tasks

• Ability to prioritize, manage multiple tasks, and meet deadlines

• Ability to stand for periods of time when performing tasks on the floor.

Education and Experience:

• Associate level - Requires BS/BA in scientific discipline or related field and minimum 2 years relevant experience. Relevant experience may be substituted for education requirement.

• Mid level - Requires BS/BA in scientific discipline or related field and minimum 4 years relevant experience. Relevant experience may be substituted for education requirement.

• Senior level - Requires BS/BA in scientific discipline or related field and minimum 6 years relevant experience. Relevant experience may be substituted for education requirement.

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.
#LI-DF1

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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