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Sr. Quality and Regulatory Systems Specialist

New England Biolabs (NEB) is hiring a Senior Quality and Regulatory Systems Specialist who will be responsible for processing of new or revised documents to be established within the Quality Management Systems. Responsibilities include management of Certificate of Animal Origin documents and liaising with the Development and Production Teams to help determine animal origin status and risk levels of raw materials and products. Additional responsibilities would include responding to international regulatory agencies and/or customers regarding questions pertaining to our products. Working with the document content owners to ensure that the documents are created in a consistent and professional format within the defined Quality System requirements and templates.   
 Primary Responsibilities: 
  • Word processing/formatting of new/revised documents within the framework of the Quality Systems software applications and templates. Documents may include the following: CofOs, SOPs, SMPs, Forms/Templates, etc.
  • Mastering and version control of CofOs/SOPs, and other controlled documents, and generation of product related documentation as needed for regulatory agencies and/or customers. 
  • Collaborating with various document owners, authors and technical resources to collect required draft content of documents to enable subsequent processing, review and approval processes. 
  • Entering data for various Quality Systems into their respective software applications. 
  • Provides guidance to Quality Assurance and Regulatory Affairs support staff.
  • Provides timely responses to regulatory agencies and/or OEM customers for NEB’s products.
  • Other Quality Assurance responsibilities, as needed.
Required Qualifications and Experience:   
  • Minimum of bachelor’s degree in chemistry, biology, engineering or related field.
  • Minimum of 4-6 years working in a manufacturing environment.
  • Biologics manufacturing process knowledge and experience.
  • Regulatory Affairs experience.
  • Excellent MS Word software training and capability for editing/document processing is required. High level of proficiency using MS Excel and Outlook is required. 
  • Exhibits strong interpersonal skills to collaborate with various Technical and Quality staff.  

Preferred Qualifications and Experience:
  • Experience working in a highly structured quality environment is preferred (e.g. ISO 9001/13485 or cGMP). 
  • Experience working with international regulatory agencies.
  • Experience using SharePoint and TrackWise eQMS software.

In order to be considered for this position, please submit your resume directly to us using either the job link in our Handshake job posting or via our company website at