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Skills

  • Statistical Process Control (SPC)
  • Inventory management
  • Human resource management
  • Employee training
  • Corrective and preventive action (CAPA) management
  • Microsoft Excel inspections
  • Team management
  • MS Office
  • Administrative support
  • Communications

Work Experiences

  • Actively shaped global validation guidelines as the representative of the the Southeast working committee on validation performance and strategy.
  • Developed a reputation for punctuality and hard work.
  • Actively shaped global validation guidelines.
  • Aligned strategies with corporate objectives.
  • Achieved on-time deliveries for 16 consecutive quarters.
  • Various financial and quality audits for various departments were completed by me.
  • Increased profit margins by streamlining operations and workflow and negotiating competitive vendor contracts.
  • Analyzed validation data trends.
  • Kept my initiative knowledge up to date by doing project management and budget management.
  • Approved final reports within 9 weeks.

Summaries

  • Communicative and team-oriented, with Salesforce expertise.
  • Looking forward to taking on a new challenge with a successful team.
  • QuickBooks and Asana experts with exceptional interpersonal skills.
  • Quality Assurance Manager who is well-versed in the use of SAP and conducts meticulous inspections.
  • Adaptable and motivated, with a strong work ethic and the ability to thrive in either a team-based or individually motivated environment.
  • Student pursuing a Manufacturing and Production degree who is eager to contribute developed knowledge in the role of Manager of Quality Assurance Validation.
  • Procedure and program have a proven track record.
  • Strategic thinker with expertise in workflow optimization.
  • Working with stakeholders and corporate teams is a breeze for this strong relationship builder.
  • Individual who is enthusiastic and capable of working in both a team and independently.

Accomplishments

  • Streamlined internal validation processes by implementing QuickBooks software, cutting paperwork by 19% and enhancing traceability.
  • Implemented data-driven decision-making processes, improving validation accuracy by 66% and ensuring fault-free product delivery.
  • Spearheaded design and execution of validation tests for 6 critical processes, enhancing operational consistency and compliance with process.
  • Led the revalidation of production facilities, achieving a 67% increase in validated system accuracy and operational performance metrics.
  • Successfully guided a team of 14 validation specialists in implementing software solutions that enhanced validation traceability and ensured data integrity.
  • Successfully mitigated risk to product lines by implementing an enhanced process for Hazard Analysis and Critical Control Point (HACCP) critical points.
  • Led periodic reviews during validation studies to ensure adherence to Good Manufacturing Practices (GMP) and implement proactive mitigation steps.
  • Orchestrated annual revalidation program planning, ensuring timely reviews and upgrades for 3 major production sites.
  • Led cross-functional teams to execute revalidation plans that cut costs by 64% while ensuring compliance with method.
  • Resolved major deviations during validation reviews, saving $5 while improving process efficiency by 21%.

Affiliations

  • Frequent contributor to the Validation Knowledge-Sharing Network, focused on the application of root cause analysis in streamlined validations.
  • Alumni of procedure Validation and Compliance Program, retaining connections through industry-relevant educational and networking events.
  • Member of the International Compliance Professionals Association (ICPA), focusing on change control and validation harmonization across global sites.
  • Representative for Harbor & Co. At the Pharma Validation Network, engaging in industry-wide validation best practice workshops.
  • Member of the Project Management Institute (PMI), with a specific focus on the workflow management and scheduling of validation activities within regulatory frameworks.
  • Quality Assurance and Validation Advisor for category, mentoring start-ups on regulatory compliance and FDA validation rules.
  • Certified Lead Auditor from category, specializing in validation lifecycle documentation and GMP compliance.
  • Co-organizer of the Annual GMP Summit, specifically curating sessions on successful validation protocol executions and facility qualifications.
  • Member of the FDA Quality Consortium, staying engaged with current and upcoming validation and process qualification regulation drafts.
  • Chapter chair for the Process Optimization Task Group in Beacon Labs, leading efforts to integrate technology into validation streamlining efforts.

Certifications

  • Pharmaceutical Industry GMP Compliance Certification - from procedure
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE) from ASQ
  • SHRM Certified Professional (SHRM-CP)
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified Regulatory Compliance Manager (CRCM) - from system
  • Intro to Computer Validation (FDA Focused) Training - from Ironclad Systems
  • Validation and Qualification Certificate - from category
  • Root Cause Analysis (RCA) Certification - from Summit Group
  • ServSafe
  • Project Management Professional (PMP)

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