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Sr. Quality and Regulatory Systems Specialist

Company: New England Biolabs, Inc.
Location: Ipswich
Posted on: September 24, 2022

Job Description:

New England Biolabs (NEB) is hiring a Senior Quality and Regulatory Systems Specialist who will be responsible for processing 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. NEB currently requires all employees located in the United States to be fully vaccinated against COVID-19. New hires must be fully vaccinated prior to the first date of employment. NEB will consider requests for reasonable accommodations, as required by applicable law. EEO Statement New England Biolabs is committed to fostering a diverse and inclusive community; as an EEO/AA employer, New England Biolabs considers applicants for employment without regard to, and does not discriminate on the basis of, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability. More in-depth details of EEO are available here. Information regarding New England Biolabs commitment to Diversity, Equity and Inclusion can be found here. New England Biolabs is a participating employer in the Employment Verification (E-Verify) program. If you need an accommodation for any part of the employment process because of a medical condition or disability, please send an email to or call 978-927-5054 to let us know the nature of your request.

Keywords: New England Biolabs, Inc., Lynn , Sr. Quality and Regulatory Systems Specialist, Other , Ipswich, Massachusetts

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