Matthew Palmisano Email & Phone Number

Hanover, Md, Us

Harmans, Maryland, United States

Switzerland 🇨🇭 , Ch

• Support activities & ensure compliance in a highly regulated GxP environment associated with control & maintenance of records.• Train departments in coordinating & implementing the application of records management policies & procedures. • Coordinate small-scale projects related to records & document management, including monitoring progress, identifying potential issues & communicating updates to stakeholders.• Create, revise, and maintain documents according to approved procedures, templates & standards using various eQMS.• Independently plan & organize work, set priorities, meet critical deadlines, and follow-up on assignments.• Provide guidance and support to colleagues on records and document management best practices and procedures.

My mother was diagnosed with breast cancer in April 2023. At this time, I decided to take some time away from work to assist in supporting her with the surgery process through her recovery. She is now doing well and in remission, and I have returned my focus to my career.

Lawrence Township, Nj, Us

• Proposes solutions for complex issues and works with management to resolve them.• Able to recognize conflict and notify management with proposed recommendations for resolution.• Prepares formal written documents and communicates problems to management with clarity and accuracy.• Knowledgeable of US and global cGMP requirements.• Comprehensively review executed batch records for documentation completeness and accuracy.• Obtain any identified GMP/GDP batch record corrections from manufacturing personnel.• Communicates effectively with other departments within the organization and functions well within a team environment.• Collects information from triage and initiates the record in the Electronic Quality Management System (eQMS) with the applicable information• Possesses good time management skills and has the ability to coordinate multiple tasks efficiently.

Indianapolis, Indiana, Us

• Participate in department optimization efforts; take the lead on selected projects and assignments, following them through to closure.• Write and assist others in writing Standard Operating Procedures (SOPs) and manage the approved SOPs.• Prepare and route documentation packages throughout the review and approval cycle.• Track document approval activities in a manual tracking system; ensuring folders are updated and accurate.• Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices.• Initiate and track periodic Documentation Binder Audits to ensure documentation in the field is current and complete.• Issue controlled Production Documentation to Manufacturing and Laboratory Logbooks to cross-functional areas; maintain Records of Issuance.• Maintain Change Control, CAPA, Non-Conformance, Complaint and Audit systems.• Manage notification to stakeholders and timely completion of Key Performance Indicators (KPI).• Manage current position training program.

Carlsbad, California, Us

• Ensures that all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any hazards, unsafe acts, or conditions in the workplace.• Accurate completion of production documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.• Knowledge of current Good Manufacturing Practices(cGMP) guidelines.• Excellent organization and time-management skills required. Must be able to manage heavy workloads and aggressive timelines promptly, prioritize, and work under pressure.• Troubleshooting of Autoclave, Fedegari, Integrity tester, Depyrogentation oven.• Production label printing.• Real-time batch record review.• Troubleshoot and change over the label machines.