Maria M. Santos

• Assist with activities of daily living (ADLs) including bathing, dressing, grooming, feeding, and toileting to enhance patient comfort and dignity.
• Identify key medical and clinical skills relevant to patient care.
• Monitor vital signs by measuring and recording blood pressure, heart rate, temperature, respirations, to support patient health assessments.
• Infection Control & Safety: Proper hand hygiene, PPE use, fall prevention interventions, and quick response to call lights.
• Clinical & Specialized Care: Catheter care, skin/wound observation, ostomy support, and specimen collection.
• Patient Mobility & Transfers: Safe repositioning, ambulation, and transferring using gait belts or mechanical lifts.
• Documentation & Systems: Updating electronic health records (EHR) systems such as PointClickCare, while maintaining HIPAA compliance.
• Soft Skills: Compassion, empathy, active listening, patience, time management, and team communication.

Administrator for Document Management System (e.g., SOPs, Test Methods, Training records, etc.).

• Maintained, updated, and archived company documents and records following company procedures; coordinated the preparation, review, and approval of these documents.
• Ensured strict adherence to cGMP standards across the organization.
• Promoted teamwork and collaboration among staff to enhance workplace morale.
• Maintained, updated, and archived company documents and records following company procedures; coordinated the preparation, review, and approval of these documents and their archiving and retrieval as needed.
• Lead Material Review Board bi-weekly meetings and ensure data accuracy.
• Responsible for maintaining QC/QA department reports to ensure weekly and monthly metrics were archived.
• Responsible for KPI monthly submission to contract manufacturing customers.
• Maintained QC/QA department reports to archive weekly and monthly metrics.
• Submitted KPI reports monthly to contract manufacturing customers.
• Oversaw batch release auditors ensuring compliance with cGMPs of the manufacturing and packaging by addressing any quality issue or prioritizing the daily workload timelines.
• Assisted in in the final review and release of manufacturing (API granulation and tabletting), and packaging batch records (dietary and OTC).
• Conducted investigations, root cause analyses, and developed corrective action plans for material/product acceptance or rejection through deviation.
• Oversaw batch release auditors to ensure compliance with cGMPs in manufacturing and packaging by addressing quality issues and prioritizing daily workload.
• Prepare new-hire employee training materials for orientation.
• Provide technical quality support for Sales/Marketing department in the completion and submission of new product specifications and labeling through Tracegains, UL, and or WERCS database.
• Drafted and executed qualification/validation protocols.
• Review and manage right-of-way documents; maintain easement records and documents in various database systems.

• Reviewed IVC manufacturing batch records and QC lab data/results for accuracy and completeness and prepared them for approval by the QC Manager.
• Communicated discrepancies or omissions found in the Batch Records with Manufacturing or QC department personnel and followed up to ensure timely resolution of such matters, involving the Senior QC manager/Supervisor when necessary.
• Documented approval/rejection of raw materials and product batches in collaboration with Senior QC Manager/Supervisor.
• Executed electronic release of raw materials and bulk products using Oracle/ERP system to ensure compliance and timely processing.
• Created stability protocol, maintained spreadsheet data, reviewed and coordinated stability studies and samples within the QC laboratory.
• Acted as a backup to the Senior QC Lab Clerk by issuing product work orders to manufacturing for production.
• Assisted the Senior QC Manager/Supervisor in scheduling and overseeing daily activities within the QC lab to verify timely testing and approval or rejection of production materials per IVC SOPs and industry regulations.
• Assisted in preparing for internal and external audits.
• Trained in Ensur software.

• Reviewed IVC manufacturing batch records and QC lab data/results for accuracy and completeness and prepared them for approval by the QC Manager.
• Communicated the discrepancies or omissions found in the Batch Records with Manufacturing or QC department personnel and followed up to ensure timely resolution of such matters, involving the Senior QC manager/supervisor when necessary.
• Documented approval/rejection of raw materials and product batches in collaboration with Senior QC Manager/Supervisor.
• Executed electronic release of raw materials and bulk products through Oracle/ERP system to facilitate timely production.
• Monitored temperature and humidity daily for two chambers. Changed charts weekly in all temperature/humidity chart recorders within the QC Lab and Manufacturing Department, ensuring proper filing of charts after removal.
• Conducted simple tablet identification tests, weight variation assessments, and Ascorbic Acid assays using the USP method.
• Served as a backup to the Senior QC Lab Clerk, issuing product work orders to manufacturing for production.

• Provided clerical support to Quality Control Lab, including filing, issuing documents, and coordinating with suppliers and service providers.
• Logged all the incoming raw material and product batches and issued proper QC lab documents required for testing.
• Issued product work orders to manufacturing for production.
• Contributed to diverse projects under the guidance of Senior QC Lab Supervisor.
• Helped Chemist manage disposal of hazardous waste in compliance with safety regulations.
• Assisted the Chemist in disposing of hazardous waste.