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Quality Assurance Specialist

Company: GreenLight Biosciences, Inc.
Location: Medford
Posted on: January 7, 2022

Job Description:

ABOUT GREENLIGHT 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-- -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,-- -protect bees and other pollinators, treat rare diseases such as-- -Sickle Cell Disease-- -as well as develop-- -vaccines for seasonal flu and the current COVID-19 pandemic.-- - 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 About the position: 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 Sr. Quality Systems Manager, the individual will be a key contributing member of our Life Science Team. The candidate will assist with creation of QMS systems and governing SOPs as well as the review of executed documents (i.e., batch records, validation protocols, etc.).-- - Additional responsibilities will relate to activities supporting the advancement of mRNA based human vaccines and other RNA based therapeutics. The ideal candidate will have experience with document control and quality systems in a regulated industry setting (e.g., FDA GLP / cGMP).-- - Key Position Responsibilities Create and implement standard operating procedures, protocols, reports etc. 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.) Review and Approve Reports (validation, stability studies, etc.) Ability to initiate and support the management of CAPAs, deviations, investigations etc. as well as monitor completion of such quality compliance activities. Provide Quality Assurance support to many cross functional teams including Development, Manufacturing, and Quality Control departments. Provide mentoring and training to staff that are new to regulatory requirements and to facilitate their use of established quality systems. Collaborates with internal and external stakeholders to ensure that regulatory agency quality assurance requirements are met. Participate in Regulatory inspection and other audits, as required. Oversight of equipment status from calibration, maintenance, validation, change control, and product changeover, etc. Identify potential compliance issues and opportunities for improvement to the overall Quality System. Provide resolution of both technical and compliance issues or gaps. Implement process improvements to enhance compliance and improve method and product quality processes (e.g. process tools creation, SOP revision, or enterprise systems implementation). Perform duties regarding special projects, as assigned by QA Management. Qualifications: Bachelor's degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 3+ years combined of experience in quality system management. Non-degreed candidates with 6+ years combined of relevant GLP/GMP quality systems experience will be considered. 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. Thorough knowledge of applicable GLP / GMP regulations, ICH & FDA guidelines, and other applicable regulatory guidance (US and EU). General understanding of Quality concepts/requirements and be able to practice and implement them, as well as GMP Manufacturing processes and drug products. Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a collaborative and engaged environment. Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels. Experience creating /reviewing / approving documentation such as Standard Operating Procedures (SOPs), Work instructions, Batch Records, protocols, etc. Experience with performing audits, and participating in audits to include regulatory agency inspections. Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges. Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook). 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. 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. GreenLight requires proof of COVID-19 vaccination for its employees consistent with OSHA guidelines. -- -

Keywords: GreenLight Biosciences, Inc., Medford , Quality Assurance Specialist, Other , Medford, Massachusetts

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