Lamonte Fields Jr Email & Phone Number

Boston, Ma, Us

Woburn, Ma, Us

- Perform routing, review, and approval activities in Part 11 compliant electronic system (Master Control)- Issued batch records, logbooks, lab notebooks, and all other secured documentation as required- Created pieces of training and performed onboarding activities within Master Control- Assisted internal and external audits by providing documentation via (AuditUtopia)

Canton, Massachusetts, Us

- Executed routing, review, and approval activities for in-process workflows within a Part 11 compliant Electronic Document Management System (EDMS) SmartSolve.- Diligently maintained multiple Excel-based databases for inventory management, ensuring accurate tracking of critical documentation and enabling efficient retrieval.- Developed a range of productivity tools that significantly streamlined batch record issuance and review processes across our product portfolio, resulting in a reduction of over 1200 hours annually for our manufacturing group.- Managed the security and retrievability of records throughout their designated retention periods by collaborating with industry-leading storage facility Iron Mountain.

New York, New York, Us

- Collaborated with Project Leads, Quality Engineers, and QA professionals on commercial/clinical campaigns as the lead Technical Writer for the COVID-19 Scale up project.- Worked closely with Process Engineers to swiftly create and revise Master Batch Records (MBRs) and Standard Operating Procedures (SOPs) for upcoming campaigns.- Successfully crafted and updated sample memos for molecule projects, ensuring clear communication and adherence to company standards.- Facilitated EDMS (PDOCs) routing, review, and approvals, ensuring seamless document workflows and compliance with company procedures.- Produced well-documented reports for molecule costing projects, enabling informed decision-making and maximizing cost-efficiency.

Billerica, Ma, Us

- Effectively controlled, tracked, and issued all Production, Stability, and Development batch records, ensuring smooth operations and regulatory compliance.- Refreshed document templates to align with evolving needs, strategically editing content for relevancy, and implementing formatting enhancements that streamlined the review process.- Efficiently created, processed, formatted, revised, expired, and controlled documentation throughout their lifecycle, including SOPs, Forms (FMs), MBRs, and more.- Diligently updated and maintained Microsoft Access and Excel database systems and logs, ensuring the accuracy, accessibility, and integrity of vital information.- Conducted New Hire and personalized small group/one-on-one training for Master Control & TrackWise, empowering users to confidently navigate and leverage our systems.- Coordinated the efficient location, preparation, and delivery of requested documentation during comprehensive audits conducted by the FDA.

Boston, Ma, Us

Launch Academy is a 10-week, immerse boot camp taking eager learners with little to no experience and teaching them what it takes to add value as a junior contributor to a software engineering team.Office Hours - users gain the ability to sign up for office hours online. - Sinatra web app with a PostgreSQL database, Foundation front end and custom CSS. - Normalized databases, writing SQL calls and tests. - Tested using Rspec and Capybara on production level app.Study Buddy - find, create or review your favorite study spot. - Ruby on Rails web app with an ActiveRecord database, Foundation front end with custom SCSS. - Incorporated AJAX functionality to allow for up to date voting on study spot reviews.

Paris, France, Fr

- Reviewed and controlled SOP's, MBR's, and various other business-critical documentation for facilities and quality systems, ensuring strict adherence to current Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP) regulations.- Fostered a collaborative and team-oriented environment by proposing interdepartmental job shadowing initiatives and developing a comprehensive implementation plan.- Provided comprehensive training and support in utilizing software systems including Livelink, Documentum, and CATSweb.- Collaborated closely with project managers to meet and exceed stringent consent decree deadlines, ensuring compliance, avoiding fines, and contributing to cost savings of tens of thousands of dollars.

Waltham, Ma, Us

- Established an off-site storage and scanning program at Iron Mountain by creating statements of work (SOW) to ensure seamless implementation and mitigate risks associated with loss or damage.- Successfully facilitated the company's transition from two decades of paper documentation to a cloud-based EDMS Master Control, resulting in improved data security and enhanced collaboration.- Coordinated the efficient location, preparation, and delivery of requested documentation during comprehensive audits conducted by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada.