Johannes (Joe) Almodovar

• Track and review change control documentation. (Veeva Vault)
• Assist with the editing of quality documents (SOPs, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.
• Must be able to work quickly with a high degree of accuracy.
• Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation.
• Translate business specifications into user documentation.
• Plan, write, and maintain systems and user support documentation efforts.

• Quality Systems and Compliance
• Management of the Quality Systems and Compliance department, including areas such as Document Control (eDMS), Product Quality Complaints, Quality Docs, Learning Management System (LMS), and Quality Management Systems (QMS) within Veeva
• Assist in managing the GMP deviation and CAPA programs, as needed
• Managing all Periodic Reviews and Document Change Controls (DCC)
• Managing the development and implementation of Quality Systems SOPs, Work Instructions, training materials, reference guides and templates
• Generate compliance metrics and prepare routine KPI reports
• Assisting in system validation activities as required (Executing UAT Test Scripts for QMS)
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements
• Streamlined internal processes for improved operational efficiency and cost savings.
• Assisting in regulatory inspections for our global clinical and commercial programs as needed.
• Enhanced team productivity by implementing efficient project management strategies.
• Developed comprehensive training programs for new hires, resulting in faster onboarding and better overall performance.

• Reviewing, revising and creating SOP’s, Forms, Protocols, Policies and Work Instructions
• Perform Document Control and Training operations within the Veeva Vault Quality Systems & ComplianceWire Systems
• Issuing/Reviewing documentation for all QMS operations (Deviations, CAPA, investigations, quality events, work orders, lot release) when required or occur
• Compiling data analysis and metrics for QA, QS, QMS, QMR and training operations
• Extensive on-floor experience managing QA operations such as: Generating and Reviewing Executed Batch records, Logbooks, Product and Release Lot Labeling for MFG, by ensuring all MFG activities are in compliance with the FDA regulations and no deviations or quality events have occurred during production
• Supported staff members in their daily tasks, reducing workload burden and allowing for increased focus on higher-priority assignments.
• Prepared comprehensive reports summarizing data analysis findings, informing key decision-makers of important trends and patterns.
• Sorted and organized files, spreadsheets, and reports.
• Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
• Managing Document Change Controls (DCC) lifecycle within Veeva Vault
• Managing Periodic Reviews of all documents and Training Matrix within Veeva & ComplianceWire systems
• Supporting Manufacturing operations (Area Clearance and Product Changeover) by ensuring that appropriate procedures are in place, validated lab equipment are calibrated and supplies are not expired for cGMP manufacturing cleaning verification and changeover activities
• Management of the Training program – TR Matrix for all cGMP employees and contractors (Veeva & ComplianceWire), SME in the use of the learning management system, deliver training and manage training programs, maintain employee’s training files, and periodically collaborate with Hiring Managers to review & develop training plan for new and existing personnel
• Lead instructor for all Veeva Vault Quality Systems Full User classroom/webinar training
• Deep process knowledge and experience assisting business partners with the creation, review, approval, closure, and monitoring of change controls and associated quality risk assessments in compliance with internal and external requirements
• Manage the On-boarding and Off-boarding program
• Manage document processing archival on-site and off-site through Iron Mountain
• Assist with QMS operations (Deviations, CAPA, investigations, quality events) as applicable
• Veeva Vault and ComplianceWire Administrator role.

• Responsible for receiving, reviewing, and processing all product inquiries and product complaints for manufactured and distributed commercial products (equipment, drug, and device) as required by applicable regulations, standards, and company policy
• Helps provide customer support and serves as a liaison between manufacturing facilities, distribution centers, customer/technical service, and customers/patients regarding distributed product complaints
• Partners with Pharmacovigilance resources on any possible adverse event (MDR/ADE) or reportable complaints, as well as with Corporate Quality Engineering on product investigations and trends
• Strong collaborative working relationship with Supply Chain, Marketing, Quality Assurance and Customer Service on all Distributed Products Investigation.
• Streamlined monitoring processes for increased efficiency and reduced response times in emergency situations.

• Managing and Operating the Records Management archiving warehouse
• (Archivist)
• Processing & retrieving archived records, collaborating with Iron Mountain
• Updating the archiving and batch record database (Livelink)
• Implementing and reconciling documents
• Reviewing, revising, and updating SOP’s (Change Owner Admin)
• Reviewing & revising incoming documents to ensure compliance with the Standard Operating Procedure and FDA regulations
• Extensive on-floor experience managing QA operations such as: Generating and Reviewing Master Batch records, Logbooks, Product and Release Lot Labeling for MFG, by ensuring all MFG activities are in compliance with the FDA regulations and no deviations or quality events have occurred during production
• Processing & managing electronic records in CATSWEB, Trackwise & Livelink Database
• Code of Federal Regulations experience and training
• Working within an cGMP environment for all record keeping
• Processing/issuing Batch records, Logbooks & NRSR (Non-Routine Sample Request)
• Preparing correspondence, reports, and spreadsheets in compliance with existing FDA, state, federal and agency laws.
• Streamlined document retrieval time for internal departments through the creation of a comprehensive indexing system.

• Generating and Reviewing Master Batch records, Logbooks, Product and Release Labeling for MFG, by ensuring all MFG activities are in compliance with the FDA regulations and no deviations or quality events have occurred during production
• Managing employees’ training records for all departments
• Processing & managing electronic records in Master Control Database
• Code of Federal Regulations experience and training
• Current Good Manufacturing Practice environment and GMP, cGMP, SOP & IP record keeping
• Processing batch records and issuing Logbooks & Sequential IPs under Quality Assurance Compliance
• Preparing correspondence, reports, and spreadsheets in compliance with existing FDA, state, federal and agency laws
• Managing the archiving warehouse
• Processing & retrieving archived records
• Updating the archiving and batch record database
• Implementing and reconciling documents.
• Streamlined documentation processes for improved accessibility and reduced retrieval time.
• Managed multiple projects concurrently, meeting deadlines while maintaining high-quality standards in documentation deliverables.
• Increased efficiency of documentation retrieval by creating user-friendly guides and reference materials for staff access.
• Provided exceptional customer service by promptly addressing internal and external inquiries regarding document-related matters, ensuring timely resolution and satisfaction.