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QA Specialist (Pack and Label)

Employer
Regeneron Pharmaceuticals, Inc.
Location
East Greenbush, New York
Start date
Aug 15, 2024
View moreView less
Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

We are currently looking to fill a Quality Assurance Specialist position to support Assembly, Packaging and Labeling. This position will support Assembly, Labeling, and Packaging operations performed at Regenerons Internal Fill/Finish facility. This position will provide floor support during production activities and contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International Regulatory Body requirements.

Available Working Schedule:

  • Monday-Thursday, 2nd shift

In this role, a typical day might include the following:

  • Oversee programs to support assembly, pack, and label operations at the Drug Product facility.

  • Develop or update, review, and approve SOPs, specifications, and other documents to support drug product operations.

  • Execute daily operations, including, but limited to:

    • Providing Quality oversight and guidance during on-the-floor manufacturing

    • Executing daily on-the-floor duties to ensure facilities, equipment, materials, and documentation comply with SOPs and safety standards.

    • Performing quarantine and segregation of material

    • Performing line clearances activities

    • Performing AQL

  • Oversee the operation of the Label Control Room, including receipt, inventory, and issuance of labels.

  • Support audits, inspections, and investigations.

  • Maintain project timelines.

  • Identify opportunities and contribute to the continuous improvement culture.

This role may be for you if you:

  • Comfort and ability to work in a dynamic environment.

  • Comfort with making decisions with limited supervision.

  • Possess ability to multi-task/own multiple projects while ensuring each is progressing as planned against defined timelines

  • Strong interpersonal and organizational skills.

  • Excel at building relationships and working/collaborating on cross functional teams

Gowning and Environment

  • Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

  • Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

To be considered for this role you must hold a Bachelors degree in Life Sciences or related field and following minimum amounts of relevant experience for each level:

  • Associate QA Specialist 2+ years

  • QA Specialist 4+ years

  • Sr QA Specialist 6+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$58,480.40 - $124,300.00

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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