Zigzag Associates Ltd

Senior Quality Assurance Manager/Auditor-GLP

FDAQRC

• Conduct GLP/GCLP audits/gap analyses/consulting; QMS design/support/remediation; CAPA support
• Identify and screen new Consultants through in-depth interviews
• Manage projects through conducting meetings and project calls, completing meeting minutes and drafting/maintaining collaboration plans, fulfilling both client and consultant needs, tracking deliverables/reports and updating project Stakeholders, evaluating the project against success criteria and managing project budgets
• Conduct peer reviews of deliverables/reports
• Support the needs of the FDAQRC Quality Management System (QMS)
• Mentoring and training of internal staff

Project Manager/Auditor

•	Identify and screen new Consultants through in-depth interviews
•	Manage projects through conducting meetings and project calls, completing meeting minutes and drafting/maintaining collaboration plans, fulfilling both client and consultant needs, tracking deliverables/reports and updating project Stakeholders, evaluating the project against success criteria and managing project budgets
•	Conduct peer reviews of deliverables/reports
•	Support the needs of the FDAQRC Quality Management System (QMS)
•	Conduct GLP/GCLP audits/gap analyses/consulting; QMS design/support/remediation; CAPA support
•	Mentoring and training of internal staff

Project Manager

Armada Nutrition

•	Oversaw compliance with established regulations and customer requirements 
•	Improved, monitored and maintained the company’s supplier qualification program 
•	Established internal procedures to certify products with regulatory agencies
•	Interfaced with outside governmental agencies, third party auditors, vendors, and customers
•	Managed manufacturing documentation revisions, including change control and deviations
•	Reviewed and approved product specifications, production batch records, labels, and COAs for raw materials and finished products
•	Conducted internal audits to ensure policies and regulations of FDA (cGMP), TDA, third party certifiers and internal SOPs were followed


Key Achievements:
►	Helped the facility achieve the highest possible rating of “AA” from British Retail Consortium (BRC) (GFSI-benchmarked food safety standard) in 2019 and 2020.
►	Facilitated weekly and quarterly team meetings with staff members and cross-functional departments which enhanced communication and increased productivity.
►	Established standard turnaround times for client regulatory requests when no response times previously existed.
►	Revamped supplier qualification and monitoring program by establishing a new process flow with enhanced documentation requirements that resulted in a more robust screening process for approval.

Regulatory Manager

Grifols

•	Oversaw center compliance with quality standards and regulations, product quality, donor suitability and donor safety
•	Conducted internal audits and hosted external audits
•	Interpreted and implemented processes, regulations and SOPs for quality control and overall regulatory compliance
•	Reviewed unsuitable test results and determined disposition of the associated results


Key Achievements:
►	Led facility to achieve Quality KPI goals for the first time in more than a year within one full month of assuming role.
►	Created Personal Development Plans with Quality team which strengthened performance and individual growth.

Quality Assurance Manager

LabCorp

Promoted to lead operations teams to quality and compliance; conducted comprehensive and focused audits across multiple disciplines. Improved and tested the Quality Management System through training, provision of guidance on regulatory and company policy compliance. Analyzed data and responded to nonconformance both internal and external to the System. 

Key Achievements:
►	Facilitated 9 external audits conducted by various agencies across 6 laboratory sites within the territory that cited only 1 minor nonconformance infraction.
►	Introduced and implemented the use of project roadmaps and stakeholder analysis in the planning and proposal phases of new initiatives with RACI charts to clarify roles and responsibilities for Quality and departmental projects.
►	Implemented weekly R.A.D.A.R. meetings with operations teams to routinely track outstanding deliverables, providing status updates on documentation of nonconforming events, continual improvements, change requests, process deviations, proficiency testing submission/performance, internal audit responses, and other/tasks items as necessary.

Regional Quality Assurance Manager

Managed manufacturing and quality control of flow cytometry reagents used in clinical trial studies conducted by various sponsors globally. Performed antibody titrations, manufactured antibody cocktails, and tested reagent quality prior to releasing reagents to study sites. Managed multiple concurrent clinical trial reagent orders.

Key Achievements:
►	Initiated successful one-on-one meetings with management to establish an avenue of regular feedback.
►	Promoted to management position after one year based on performance.

Project Specialist, Clinical Trials

Performed all aspects of cytogenetics/FISH testing including specimen processing and chromosome analysis. Wrote, updated, and edited laboratory SOPs. Wrote validation plans and reports for validation studies. Led employee training.

Key Achievements:
►	Utilized internal subject matter experts as trainers for processes/tasks within the Cytogenetics/FISH departments which increased consistency and improved training outcomes.
►	Performed troubleshooting studies and established optimal processing procedures for new reagents implemented and generating less than optimal results.

Cytogenetics Technologist – Integrated Oncology / LabCorp

Cytogenetics Laboratory Assistant / Technologist Trainee, Integrated Oncology / LabCorp

I help pharma and biotech organizations reach their goals beyond just checking the compliance box with a broad range of GxP Quality Assurance and Regulatory Compliance Management experience. 

My technical focus is primarily GLP/GCLP: 
-Audits/vendor qualifications 
-Gap analysis
-Quality Assurance consulting
-Quality Management System (QMS) design/support/remediation
-Corrective and preventive action (CAPA) support

Examples of therapeutic areas and discipline expertise include:
-Oncology
-Cytogenetics/FISH
-Immunology
-Immunohistochemistry
-Pathology
-Histopathology
-Flow Cytometry
-Molecular Genetics/NGS
-Toxicology
-Biomarkers

SIGNATURE STRENGTHS:
► Internal/External Audits
► Quality Management Systems
► Vendor Management 
► Project Management
► Policy & Procedure Development/Implementation 
► Corrective and Preventive Actions
► Training Development/Delivery 
► Process Improvement Activities
► Cross-functional Communicator/Advisor/Liaison 

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