MARIANGELYS MALDONADO

Work History

ABBVIE BIOTECHNOLOGY LTD

Barceloneta, PR

01.2022 - Current

Responsible for conducting comprehensive internal audit program and ensuring that Internal audit system is effectively implemented.
Handling external regulatory inspections and on the resolution of regulatory compliance issues
Review the acceptability of Action Plan and Corrective and Preventive Actions (CAPAs) resulting from audit observations.
Review plant procedure for compliance with company policies and general practices.
Administrate/coordinate plant Inspection Readiness activities.
Coordinates and issues the Product Quality Review documents per the scheduled timeframe.
Maintains ABL staff informed of regulatory changes that may impact the plant operations.
Assists QA Compliance Manager in keeping Regulatory documents up to date.
Responsible for the Annual Product Review evaluation.
Involved in Operation Compliance, regulatory, third party and client audits as facilitator, back-room support.
Coordinate the Management Review Quarterly Meetings.
Support in the Change Management process.
Support the Regulatory Filing Process reviewing the data and documents.

ABBVIE BIOTECHNOLOGY LTD

Barceloneta, PR

01.2019 - 01.2022

Established the audit process and reviewed manufacturing procedures before the release of products.
Audited and archived API and final Drug Product digital and paper batch records to comply with GMPs, business procedures, company policies, and regulatory guidelines.
Approved manufacturing exceptions for production support worksheets in glass washer, weight, and dispense areas.
Collected deviation proposals for procedures and specifications that sustain product quality prior to release.
Audited batch record deviations and evaluated corrective actions.
Worked closely with Manufacturing, Tech Ops, MS&T, and MQA to track and evaluate procedural discrepancies and generate processes to reduce errors.
Reviewed manufacturing, equipment operations, and facilities on a regular basis to maintain compliance.
Updated SAP materials and resource data based on testing and regulatory agency conformity.
Drafted and delivered certificates of analysis and compliance for API and finished Drug Product
Submitted batch data into the lot restriction management system.
Compiled the batch record review package and categorized per approved retention procedures.
Facilitated weekly meetings, discussed batch record discrepancies, and supported internal audits to ensure production plant compliance with manufacturing requirements.

ABBVIE BIOTECHNOLOGY LTD

Barceloneta, PR

01.2016 - 01.2019

Reviewed Third party Manufacturing (TPM) Production Batch Records, Worksheets, and Changeovers to consult production teams.
Worked closely with third party manufacturers to maintain quality and submit exception reports.
Ensured quality standards, business procedures, document changes, Current Good Manufacturing Practice (cGMP), and Corrective and Preventive Action (CAPA) methods are practiced throughout the production process.
Investigated Third party Manufacturing (TPM) events, documented production processes, and encouraged operator ownership of equipment.
Consulted cross functional teams, project teams, and department leaders on quality assurance.
Proofread, evaluated, and updated documents, batch records, and Standard Operating Procedures (SOPs) to maintain cGMP standards and procedures.
Audited the Quality System on a regular basis to continually revise business processes, implement effective measures, and transform production to meet company requirements and timelines.

ABBOTT BIOTECHNOLOGY LTD

Barceloneta, PR

01.2004 - 01.2006

Relocated to Worcester, Massachusetts to transfer the Bulk Drug Substance process.
Consulted on the design of processes for the Media Preparation, Buffer Preparation, and Buffer Hold Areas, including MES and Delta V systems, standard operating procedures, and Solution Record Changes.
Worked closely with the Central Services Department to ensure production compliance of equipment and manufacturing processes.
Prepared Solutions for Inoculums, Fermentation, Capture, and Purification areas.
Directed Cleaning in Place (CIP) and Sterilization in Place (SIP) to cleanse process tanks prior to production.

ABBOTT DIAGNOSTICS

Barceloneta, PR

01.2000 - 01.2004

Collected and archived bulk resources and printed materials.
Evaluated equipment and work areas to ensure production is free of all previous process materials, cleared production to start manufacturing, and inspected production processes during manufacturing.
Perform the line clearance, AQL inspection and line inspections during the manufacturing process.
Audited Batch Records to prioritize general manufacturing instructions and ensure compliance before, during, and after production.
Directed preventive and scheduled maintenance to laboratory equipment, IMX platforms, and AxSYM systems.
Conducted product and production tests including product efficacy, rate monitoring, and push apart.
Audited resources and materials during production to verify quality and quantity necessary for manufacturing requirements and standards.