Laura Isa Rodriguez-Baez

· Accountable for the overall administration of the Quality Investigations and Corrective and Preventive Action quality system by supervising and monitoring the performance of the Investigations and CAPAs and report and analyze metrics.

· Responsible of the evaluation and approval of the Quality Investigations and Corrective and Preventive Action records.

· Serves as the main contact and partner with other J&J affiliates and JSC functions and receives complaints from other J&J affiliates related to product manufactured at the site and coordinate strategies for the investigations management.

· Serves as Subject Matter Expert, Process Owner and SMR preparation contact in regulatory inspections and serves as Subject Matter Expert. Follow- up and assures appropriate closure of any outstanding GMP issues from internal and external audits.

· Develops, coordinates, and provides compliance and general GMP training.

· Reviews and approvals of procedures, protocols and other documents related to Quality Investigations and CAPAs.

· Responsible of the Strategic implementation of the Investigations and CAPA system remediation plan including the creation of the investigators and approvers organization, learning roadmap and qualification.

· Driver of excellence in the investigations and CAPA system at site and global level

· Creates and Implements the Investigations and CAPA Governance

• Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
• Evaluated quality problems and performed assessments to identify and resolve issues.
• Improved quality processes for increased efficiency and effectiveness.
• Updated quality control standards, methods, and procedures to meet compliance requirements.
• Responsible of the implementation and compliance with the Quality Systems within the Manufacturing/Operations Department
• Responsible of providing guidance to the entire department on the Quality Systems.
• Provide QS update to different managerial levels.

· Responsible of the implementation and compliance with the Quality Systems within the Manufacturing/Operations Department which caused a reduction of 80% of investigations related to non-compliance issues

· Supervise manufacturing operators that resulted in an increase of the Performance Values of the machines in a 13% in 2 months by allocating resources as needed and providing incentives to employees.

· Lead the Quality Risk Management activities related to the implementation of work in-process materials optimization and equipment compliance-based flexibility reducing the equipment downtime while complying with segregation requirements.

· Facilitate the batch record review process and product disposition by the immediate resolution of the incidents related to the records and documents reducing the resolution time in 80%.

· Implement the housekeeping program in the site and extending the scope of the program to other sites coordinating multidisciplinary efforts as a Site Process Owner.

· Improve the investigations triage process by leading the multidisciplinary team to compliance and scientific based decisions.

· Optimization of current electronic systems to provide automatic reports of the data generated for the Annual Product Review. This activity improved the cost of the area contribution by reducing the resources assigned to the task in at least an 85%.

· Develop and flawlessly execute the strategy for the revision of Standard Operating Procedures for compliance with regulatory requirements.

· Audit the manufacturing areas and identify trends or on-going tendencies in terms of investigations and documentation incidents, root causes and CAPAs to implement actions.

· Direct supervision of manufacturing investigators, acting as the area manager as requested, achieving the implementation of the investigations’ new governance, decreasing the cycle time by 20%.

· Act as the Site Process Owner for Manufacturing Controls and a Subject Matter Expert and Back Room representative on internal and external (regulatory and third-party) audits which resulted in zero observations for the last 2 years.

· Reviewed and approved site non-compliant events/investigations including laboratory, manufacturing packaging, warehouse and Engineering Departments which contributed in being recognized as the first QA Representative having the Right First Time ranking after the third- party evaluation of investigations.

Ensured Quality Systems were in accordance with the Good Manufacturing Practices by managing investigations trends and notifications to site and corporate management.

· Direct support to supplier audits and Quality Agreements issuance and review. Support to suppliers’ investigations resulted on an increase by 80% on the right first time of the investigation.

· Conducted training regarding investigation writing for Lead Investigators and QA personnel.

Substituted the QA Manager as designated

· Conducted laboratory and manufacturing investigations, including analytical and microbiological, technical operations, complaints, engineering, quality systems, compression, packaging and product development areas which resulted on being top ranked as the first area certified during regulatory process.

· Supported general internal/external and regulatory audits which resulted in zero observations in six years.

· Lead the revision of the PR campus investigations' procedure which resulted in the standardization of practices.

· Developed the qualification program for new investigators qualification program and provide direct supervision of the program obtaining a decrease of 35% in the training time.

· Accountable for keeping Right First Time (RFT) investigation metrics and escalation to management of compliance issues.

· Assist supervisor in multiple tasks assigned, as requested. Worked in direct tasks supervision to ease manufacturing processes by reviewing laboratory analytical data.

· Assist laboratory analysts during tasks performance.

· Finished Product analytical laboratory testing.

· Responsible of the laboratory cycle time and product code throughput time.

· Approved the laboratory analytical data (raw materials, in-process testing, stability data/reports and finished goods), which resulted in the decreasing of the cycle time of the approval by 20%

· Implemented a guidance for Good Documentation Practices which supported the training process of new employees.

· Created the Central Distribution Area in which the Controlled Substances and the laboratory samples were received for testing the Certificates of Approval were generated, the Quality Systems were handled, and the procedures were revised. This creation improved the laboratory cycle time by 50% and improved the costs by 82%.