Alex Tramontana

Successfully led the qualification and site approval for two new (2) ICL manufacturing sites located in Lake Forest, CA and Nidau, Switzerland.

Developed validation and regulatory strategy for notified body approval (DEKRA).

Ensured validations protocols met all procedural requirements.

Ensure change control requirements were met for any process changes.

Served as Subject Matter Expert for the qualification of:

• ISO 7 & 8 cleanrooms
• Bioburden and Environmental Monitoring Program
• High Purity Water Systems
• Clean Steam Generators
• Autoclaves
• Compressed Dry Air System
• Nitrogen Gas Systems

Developed Failure Mode Effects Analysis (FMEA) for new facilities and utilities system.

Led a team of 8 Quality Engineers and 3 Managers for the qualification domestic and international manufacturing sites.

Successfully led STAAR Surgical Co in receiving MDSAP (Medical Device Single Audit Program) program approval.

Organized and Chaired the Quality Management Committee, to ensure appropriate escalation of potential quality/regulatory issues Management with Executive Responsibility.

Acted as main point of contact for FDA and notified body inspections.

Served as Recall Coordinator, direct interface with Global Health Authorities. Organized assignments of recall actions including leading, tracking product recall activities to recall termination.

Tracked global regulatory submissions to ensure accuracy and timely responses.

Authored, reviewed, and approved regulatory submissions.

Organized and published final responses to FDA 483 and notified bodies non-conformances.

Authored Heath Hazard Evaluations to determine end user risk for non conformance product evaluations.

Supported professional advancement of QA and RA staff.

Overhauled CAPA and non-conformance systems to implement root cause analysis methods.

• Perform QA peer review and approval of investigations, protocols, technical assessments, CAPA, customer complaints, and process control documentation for clients
• Serve as the QA Lead in cross functional process, monitoring/troubleshooting, and process improvement teams
• Triage manufacturing issues to determine product impact and immediate corrective actions
• Work in collaboration with Operations, Technical Services, Supply Chain, Deviation Writers, and QC Laboratory to ensure that Quality in the organization is consistent in application, ensuring GMP compliance
• Perform Quality Audit at the client’s facility to determine FDA inspection readiness
• Participate in client’s Material Review Board (MRB) sessions for consistency and to ensure GMP compliance

• Authored / managed investigations and customer complaints to meet key timing commitments, with well-investigated and well-documented reports
• Determined scope, product impact, root cause, and corrective actions for deviations from manufacturing procedures by interviewing, sampling, and applying the use of quality tools and techniques
• Worked with the Manufacturing Science & Technology, Subject Matter Experts, and Quality Approvers to determine the breadth and scope of the investigation, to identify the appropriate root cause, implement corrective actions, complete trending analysis, and recommend product disposition
• Determined appropriate corrective actions and preventative actions (CAPAs) to prevent reoccurrence of the deviation with realistic timelines for completion
• Put complex thoughts and issues into writing in such a manner than an educated, but uninformed reader can understand and make decisions based on the written investigation report
• Illustrated strong communication, project management, and leadership skills, including the ability to interact and influence others at various levels of the organization
• Provided oversight to the calibration program at Sandoz

• Provided on-site investigational and CAPA training to QA personnel
• Provided over-site to Management Review Board (MRB) process
• Determined the appropriate corrective actions and preventative actions (CAPAs) for critical deviations
• Performed Regulatory body readiness audits
• Provided deviation and customer complaint metrics to site leadership

• Managed all Quality Assurance aspects of EAS Sports Nutrition products
• Performed qualification audits of Third Party Manufacturing sites for EAS products
• Managed banned substance and contaminant program for all of EAS products
• Served as EAS’s Quality liaison for EAS products used by professional sports teams
• Performed quarterly Quality performance reports for senior management review
• Implemented and maintained Standard Manufacturing Agreements for all EAS’s Third Party Manufacturing Sites
• Managed qualification runs for new product launches from conception to final product release

• Conducted failure investigations for systematic Quality issues (CAPA)
• Chaired Management Review Board for two manufacturing sites
• Conducted HACCP projects for feeding tube sets
• Authored all deviations reports and customer complaints issued for the Device Manufacturing Center and Pump Service Center
• Served as a board member of the Class III clean room facility upgrade
• Conducted Quality History Study for Environmental Monitoring Program for Class III clean room
• Served as QA Hold Coordinator for all commodities/finished products placed on QA Hold
• Authored QA Hold Procedure for the Device Manufacturing Center
• Reviewed and approved Quality Agreements for key component suppliers and Third Party Manufacturing (TPM) Sites
• Performed Quality Audits for key component suppliers
• Maintained Calibration Program for the Device Manufacturing Center and Pump Service Center

• Managed direct reports work assignments
• Perform batch correction calculations
• Implemented standard commodity values for batch yield calculation
• Developed and implemented new final water calculation procedure
• Performed performance reviews for direct reports
• Performed final batch audit for Quality System Review

• Managed domestic analytical results for international FDA inspections
• Prepared products reports for ANDA submissions
• Handled MER (Material Evaluation Reports) and investigations for OOS results
• Performed lyophilization mapping studies on all freeze dried products
• Managed stability program for all approved products and pipeline products