Quality Assurance Specialist Lead

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ABOUT GREENLIGHT

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GreenLight Biosciences solves big problems facing society in agriculture, human health, and animal health through scientific innovation. GreenLight Biosciences is dedicated to bringing our cell-free RNA production process to market. Our work will lead to more sustainable global development, and we promise to deliver our safe solution without compromising the Earth and its people. One of the small coterie of early RNA-focused biotech startups, GreenLight Biosciences was founded in 2008, raised its ****rel=no-follow>most recent round this year and has a broad portfolio addressing key issues in plant health and human health. The GreenLight team is over 200 people across our headquarters in Medford, MA, an R&D facility in Woburn, MA and an R&D facility in Research Triangle Park, NC. GreenLight also has a pilot scale biomanufacturing plant in Rochester, NY. Initiatives include finding ways to support biodiversity, ****rel=no-follow>protect bees and other pollinators, treat rare diseases such as ****rel=no-follow>Sickle Cell Disease as well as develop ****rel=no-follow>vaccines for seasonal flu and the current COVID-19 pandemic. 

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At GreenLight, we believe inclusion is the way forward. We celebrate the power of working together to address humanity’s challenges, meet the needs of underserved populations, and push the boundaries of scientific discovery. Fueled by our aspiration for a true sense of belonging, our talented teams embody the principles of diversity and equality as we strive to bring food security, medicine, and healthcare to everyone—paving the way for a sustainable future. For more information, visit ****Descriptions/****rel=no-follow>****the position:

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The GreenLight team is looking for a self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. The company is looking for a key individual to play a pivotal role in advancing breakthrough therapies to rapidly address emerging pathogens. Reporting directly to the QA Manager, the individual will be a key contributing member of our Human Health program team. The candidate will assist in establishing and maintaining the document control systems necessary, assisting and maintaining some key aspects of the QMS system and additional responsibilities related to day to day to support the advancement of mRNA based human vaccines and other RNA based therapeutics. The ideal candidate will have experience in both document control support and quality systems in a regulated industry setting (e.g., FDA GLP / cGMP).  Candidates with either paper-based and /or electronic (e.g., Qualio, Veeva, etc.) system experience will be considered.

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Key Position Responsibilities

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• Responsible for the administrative oversight of the electronic quality management system, including:
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• The creation and maintenance of user accounts in the existing (i.e., Qualio) system.
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• Help with conversion to and implementation of Veeva
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• Will create and implement standard operating procedures aimed at guiding staff through various document control processes (to include but not limited to):n
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  • Document Control
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  • Change control
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  • Retention policy
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  • Quality Systems (deviations, CAPAs, etc.)
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• Perform Documentation coordination activities to:n
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  • Review and approve GMP raw data for compliance
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  • Review and approve Quality system and batch related documentation (e.g., cGMP procedures, batch records, solution records, QC testing, Certificates of Analysis, protocols, and reports, etc.)
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• Provide assurance that SOPs, Test Methods, Raw Materials, Quality Control (QC) external testing and Forms, Specifications and Certificate of Analysis, and other documentation are reviewed, approved, and archived in a timely manner.
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• Provide Quality Assurance support to many cross functional teams including Development, Manufacturing, Quality Control departments.
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• Provide training to GreenLight team members so that they understand the importance of document management and good documentation practices to ensure successful business outcomes.
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• Provide mentoring and training to staff that are new to regulatory requirements, to facilitate the use of established quality systems.
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• Collaborates with internal and external stakeholders to ensure that regulatory agency quality assurance requirements are met.
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• Support key quality processes and systems related to external CRO or CMOs, to include preparing correspondence (e.g., NDAs, QAAs, audit reports, etc.)
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• Participate in Regulatory inspection other audits, as required.
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• Oversight of equipment status from calibration, maintenance, validation, change control, and product changeover, etc.
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• Perform duties regarding special projects, as assigned by QA Management.
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 Position Requirements

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• Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 4 years combined of experience in documentation and quality system management.n
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  • Non-degreed candidates with 8 years combined of relevant GLP/GMP document and quality systems experience will be considered.
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• Self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
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• Thorough knowledge of applicable GLP / GMP regulations, ICH & FDA guidelines, and other applicable regulatory guidance (US and EU).
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• General understanding of Quality concepts/requirements and be able to practice and implement them, as well as GMP Manufacturing processes and drug products.
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• Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
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• Experience with creating documentation such as Standard Operating Procedures (SOPs), Work instructions, Batch Records etc.
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• Experience initiating and completing deviations, CAPAs, etc.
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• Electronic document management system experience preferred along with the ability to create / conduct document management training sessions.
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• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.
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• Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).
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Greenlight Biosciences Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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GreenLight requires proof of COVID-19 vaccination for its employees consistent with OSHA guidelines.

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