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QA Specialist (MES)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Jun 7, 2024

View more

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 the Manufacturing Execution System (MES). This position will support a cross functional team of MES Specialists by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. We are looking for someone who can continuously provide QA input and feedback in accordance with regulations, policies and procedures.

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

  • Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact

  • Identifying difficulties and suggesting alternatives that are aligned with QA

  • Reviewing MES change controls and test plans

  • Working with Technical Trainers to develop QA training plans for MES users

  • Collaborating in the creation, review, and approval of validation documents

  • Reviewing and approving MES recipes, design specifications, master batch records, and electronic records to meet the requirements of manufacturing and QA users

  • Supporting Pre-Production Executions (Pre-PE) and delivering feedback

  • Providing end-user support for MES usage and working closely with IT to troubleshoot problems associated with QA functions

  • Support/lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team

  • Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures

  • Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.

  • Accountable for maintaining project timelines associated with quality assurance initiatives

  • Perform On-The-Floor quality review of documents

  • Review and approval of documents including executed Batch Records and SOPs (electronic and paper-based)

  • Execute daily operations per strategic direction in a multifaceted environment.

  • Provide mentorship during on-the-floor manufacturing

  • Support audits, inspections and investigations.


This role may be for you if you:

  • You have previous QA operations experience, particularly with batch record review / MES design, implementation or training

  • You are a strong communicator and can use effective communication while collaborating with other functions

  • You are driven and self-motivated

  • You seek out new ways to improve processes and make changes accordingly

  • You enjoy project work in a fast paced, startup type environment

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

  • Senior 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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