Quality System and Document Control Specialist

The successful candidate will have experience working within a GMP pharmaceutical/biotech environment and will be expected to interact with personnel across all levels and functional areas within the company. The position will encompass various tasks, including but not limited to, supporting selection and implementation of e-systems for document management and quality system management, administering GxP documentation workflows and quality records; safeguarding and retaining site quality records; coordinating issuance, retention and archival of quality records; maintaining metrics and monitoring the periodic review process; and other additional Document Control responsibilities as assigned to facilitate and/or support implementing training system, vendor and supplier quality management including raw material release. This position reports to the Director of Quality Assurance.Key Responsibilities:Maintain a document control system and processes according to the cGMP and in compliance with all applicable regulations.Create document management standards, templates and formatting requirements for the Metagenomi document management system.Support identification, selection, user acceptance testing, implementation and rollout of an electronic document management system and eQMS.Administer workflows and perform compliance reviews of draft documentation/document change controls as they are processed through Metagenomi''s electronic Document Management System.Develop, oversee, and execute document control procedures including the creation, routing, review, approval, distribution, periodic review and archiving of new and revised controlled conjunction with training staff, develop and provide Document Control compliance and system training, as well as training for other programs within scope of responsibility as a designated SME.Maintain inventory tracking logs and oversee issuance of controlled numbers utilized to support other GxP business processes.Issue, track, reconcile and archive paper records, e.g., controlled forms, batch records, laboratory notebooks and all other GxP records.Establish and Manage the GMP documents archival vault in-house and external storage.Assist in compiling quarterly KPI/metrics and performing trending analysis of the Document Control system to ensure compliance and drive continuous improvement plete cross functional training and backup support to Quality Systems team members.Support creation of training materials and training execution for Quality System and related QA functions.Provide eQMS system administration support as needed.Support establishing corporate training program and management of the training module eQMS system.Performs other duties as assigned with the Quality Assurance functions.Propose and drive process improvements throughout the quality system with a focus on documentation.Assist in inspection readiness and during inspections.Desired Education & Skills:A bachelor''s degree and 5-7 years experience in a related position or high school diploma and 10+ years experience in a regulated environment; preferably reporting into a QA function.Knowledge of eQMS and regulatory requirements including 21 CFR 11, 210 and 211, ICH -Q10 and data integrity.Familiar with Veeva Vault, Trackwise or other electronic document/training management system and electronic quality management system a plus.Advanced proficiency in Microsoft Word, including editing, formatting, creating/utilizing templates, creating forms, embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required.Must be flexible, organized, detail-oriented, and able to handle multiple priorities in a fast-paced environment.Excellent oral/written communication, problem solving/issue resolution, and prioritization skills required.Excellent formatting, composition, grammar, editing and communication skills to make documents appropriate for the needs of users.Ability to work independently and in team environments, understanding of GxP Quality Requirements and familiarity with Good Documentation Practices and ALCOA concepts.Experience training personnel on Document Control, Records Management and/or Quality Assurance concepts.About MetagenomiAt Metagenomi, we are accelerating innovation in gene editing with a wave of proprietary CRISPR-based systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful therapeutic tools that can be leveraged by partners and fuel our own pipeline of potentially curative medicines. Our goal is to revolutionize gene editing and unlock its power for the benefit of patients around the world.What makes Metagenomi a unique place to work?We are passionate about developing technologies derived from microbial-rich ecosystems that have the power to enable therapeutic development and the potential to cure devastating disease.We have cultivated an amazing culture that values teamwork, curiosity, scientific rigor, and fun.We offer competitive compensation including a market-benchmarked salary, annual target bonus, equity in an early-stage startup, and a comprehensive benefits plan, including 401(k) matching, a retirement safe harbor plan, and other perks. As this role is open to candidates with a wide range of skills and experience, the salary range will be dependent on the exact level of the position. A more specific level-based range will be provided to you during the early stages of the interview process. We value transparency and will make every effort to provide you with a succinct explanation for how the range is determined.At Metagenomi, we know that our people drive our success. Metagenomi provides an open, collegial, and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We are an equal opportunity employer and believe in and value diversity and inclusion. All employment is decided based on the qualifications, merit, and business need.If you need assistance or accommodation due to a disability, you may contact us at and we would be happy to help.

Created: 2026-03-07