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Skills

  • Wages and salary
  • Organization
  • MS Office
  • Contract negotiation
  • Client Satisfaction Improvement
  • Employee relations
  • Certification acquisition
  • Recruitment
  • Process improvement
  • Cross-functional collaboration

Work Experiences

  • Accomplished this in 2023.
  • Collaborated with cross-functional teams to update qualification processes, resulting in a 7-day reduction in cycle time in 2024.
  • Created timelines for projects in Boston.
  • Assessed technical documentation for Jira qualifications.
  • Aided in reducing product deviations by 24% year-over-year.
  • Achieved a 12% faster qualification-to-market timeline.
  • Achieved 24% accuracy in regulatory submissions.
  • Improved office processes, such as record tracking and system, by implementing process improvements.
  • Collaborated with suppliers.
  • Authored and maintained accurate certification tracking logs for 11-plus ongoing qualification projects.

Summaries

  • Achieved a 67% reduction in product deviations year-over-year.
  • Authored clear and effective qualification procedure guidelines, drastically reducing review deviations by 50% and improving overall process outcomes.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the system business.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Conducted rigorous audits.
  • Dynamic Assistant Manager of Human Resources with 7 years of experience advising on human resource topics and issues.
  • Clear understanding of quality assurance and vendor management as well as strategic planning training.
  • Championed data-driven decisions.
  • Analyzing company needs and developing long-term solutions to meet personnel objectives is second nature to me.

Accomplishments

  • Implemented a new monitoring system to review and track qualifications, increasing transparency and reducing errors by 69%.
  • Collaborated with team of 15 in the development of initiative.
  • Implemented qualification audits, resulting in the identification and correction of potential bottlenecks, increasing operational efficiency by 52%.
  • Partnered with the compliance team to align all qualification procedures with new international standards, ensuring Six Sigma achievement by 2019.
  • Reduced qualification delays by implementing a new time-management system, improving project deadlines by 22%.
  • Spearheaded the company’s acquisition of a ITIL by overseeing the qualification processes and ensuring 100% adherence to standards.
  • Worked closely with research teams to ensure empirical data supported qualification standards, accelerating project approvals by 5 weeks.
  • Provided detailed risk assessments during the qualification process, reducing potential failures by 46% and ensuring seamless product rollouts.
  • Managed the qualification of 3 third-party vendors, ensuring compliance with industry standards and mitigating legal risks.
  • Collaborated with legal teams to update qualification procedures based on evolving procedure, ensuring risk mitigation with 35% compliance.

Affiliations

  • Society for Mechanical Engineering in Pharma Industry (Chicago)
  • International Safety Equipment Association (ISEA)
  • American Medical Informatics Association
  • Jaycees
  • Conference of Western Attorneys General (CWAG)
  • National Association of Social Workers
  • Society of Manufacturing Engineers (SME)
  • Society of Women Engineers
  • Institute of Industrial and Systems Engineers (IISE)
  • International Association for Six Sigma Certification (IASSC)

Certifications

  • Certified Documentation Improvement Practitioner (CDIP)
  • Certified Quality Auditor (CQA) Harbor & Co.
  • CompTIA Security+
  • Certified Information Systems Auditor (CISA)
  • Supplier Risk Management Certification – framework
  • Microsoft Certified Systems Engineer (MCSE)
  • Root Cause Analysis Training Certification – category
  • ISO 13485 Internal Auditor Certification
  • Project Management Professional (PMP) - PMI
  • Certified Process Improvement Specialist – Asana 2015

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