Servier Pharmaceuticals

Quality Assurance Manager

Fresenius Medical Care North America

 Interfacing directly with suppliers to follow up on quality and performance issues; managing Supplier Corrective Action Requests.
 Role as Lead Auditor - performing audits on Fresenius Pharma CMOs within the intercontinental United States and Europe.
 Performing on-site and remote supplier quality audits for new suppliers; participating in supplier approval process.
 Documenting and following up on audit results and required actions to be addressed by the supplier.
 Tracking, analyzing, and reporting supplier performance metrics to stakeholders within quality, logistics, and manufacturing management using the appropriate software tools.
 Performing problem analysis, process, and machine capability studies; determining and proposing statistical process controls for appropriate supplier processes.
 Developing professional expertise; applying company policies and procedures to resolve a variety of issues.
 Working on problems of where analysis of situation or data requires a review of a variety of factors. 
 Building productive working relationships.
 Providing assistance to staff with general tasks that require a better understanding of functions.
 Exercising judgment within defined procedures and practices to determine appropriate action. 
 Reviewing and complying with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
 Responsible for Supplier Management.

Supplier Quality Engineer II

Green Key Resources

 Interfacing directly with suppliers to follow up on quality and performance issues; managing Supplier Corrective Action Requests.
 Tracking, analyzing, and reporting supplier performance metrics to stakeholders within quality, logistics, and manufacturing management using the appropriate software tools.
 Performing problem analysis, process, and machine capability studies as required; determines and proposes statistical process controls for appropriate supplier processes.
 Developing professional expertise; applying company policies and procedures to resolve a variety of issues.
 Building productive working relationships.
 Exercising judgment within defined procedures and practices to determine appropriate action. 
 Reviewing and complying with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
 Responsible for Supplier Management.

Supplier Quality Engineer (Consulting for Fresenius Medical Care World Headquarters)

Sanofi-Genzyme

Activities include but are not limited to: 
Performing record review necessary to ensure the compliance of manufacturing procedures to inhouse specifications and government regulations on the manufacturing floor 
Conducting reviews of manufacturing processes to ensure compliance 
Conducting reviews of testing results in support of release of intermediates 
Interpret complex, explicit documentation to ensure quality standards and compliance
Managing the facilitation with Project Management qualities of the creation and revision of company procedures as a Document Change Owner and other initiatives (responsible for training new employees, ensuring all onboarding activities are set for new hires, assigning/overseeing projects given to others within Quality Assurance). 
Mentoring junior staff and new hire’s within the Quality Assurance Department through being a Subject Matter Expert (SME) and facilitating training, performing on-boarding activities (ie assigning proper curricula’s pertinent to function, overseeing projects assigned, performing on-going check-up meetings).

Senior Quality Compliance Specialist

The Judge Group

QA Compliance Specialist Consultant

Lonza Biologics

Site is a Contract Manufacturing Organization (CMO).
Activities include but are not limited to: Audit, review, and authorize in process and finished product batch records, applicable product documentation (ie. product specific and suite logbooks), and solution records for conformance to company established procedures and government regulations. Ensure conformance to SOPs and regulations prior to product release. Report non-conformances for reconciliation and perform follow through and action items for closure. Assigned to customer and responsible for being a liaison between Lonza and the customer. Respond to all customer questions/requests. Perform real time review within the Manufacturing suite floor. Work with Manufacturing real time for issue resolution within the suite floor. Apply Operational Excellence through out the Manufacturing and Quality Assurance (QA) process for lean manufacturing. Conducted product readiness activities such as required training for best documentation practices and other pertinent areas for suite/product start-up.

Quality Assurance

Pfizer/Wyeth Biotech

Activities include but are not limited to: Obtained Green Belt Certification in Operational Excellence. Responsible for all activities related to Manufacturing Batch Records review and Quality Batch Records. Responsible for activities all of which are related to setting and maintaining quality standards aligned w/FDA, cGMP, EMEA and other applicable international GMP regulations & guidance's. Facilitating best practices for Manufacturing Batch Record review process and disposition activities of global product. Reviewed documents for end of inoculum. Responsible for, and facilitated, entire department's training program/curricula. Performed data analysis for product and system investigations. Created and performed training for onsite systems.

Over seventeen years of experience in Biologics, Biotech and Pharmaceuticals. 

Certified Biomedical Auditor.

Outstanding knowledge of Quality Standards, cGMP, cGDP, and FDA regulations. Excellent experience in areas such as; internal/external audits, consent decrees, batch record review, training/mentoring staff, identifying areas of improvement, document change owner, creating procedures, deviations (CAPAs, Change Controls), creating training programs, and building a culture where departments such as Quality and MFG are working collaboratively for the outcome of the best product being made.  

Certified Quality Lead Auditor. Being a change agent within an organization to bring tools such as; Lean MFG, Six Sigma, Kaizen, Operational Excellence, and being certified with green belt to empower all and myself to not just simply take status quo though pose a challenge. One item that is known opposed to everything for the future is that Change is inevitable and will occur whether one is ready or not. Embrace it and one will go far.

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