Senior Quality Consultant
- Responsible for coordinating compliance activities and audits by working with client's nonclinical groups and other related functional team members and contract auditors.
- Provided GCLP/GCP auditing support by performing audits of nonclinical laboratory facilities, nonclinical reports and data and Certificates of Analyses generated by an analytical laboratory
- Evaluated significance of audits findings and coordinate the findings response with client departments, nonclinical facilities, CROs and/or clinical investigational sites
- Periodically perform clinical site audits, CRO evaluations/audits, clinical system audits, master files audits and clinical document audits
- Review clinical documents including protocols, amendments, sample case report forms, and sample informed consent forms for adequacy and compliance.
at this job
Software Quality Consultant Kelly
- Validation QA lead on three regulated SDLC and software validation business critical projects.
- Created and managed software development validation and control processes.
- Provided company-wide Quality Assurance improvements.
- Project Management using Microsoft project management.
- Developed new procedures, forms, and templates for software design and process validation.
- Created the Software Vendor Compliance (audit) Checklist and performed supplier audits.
- Developed Internal Monsanto Software Audit Checklist and assessed the compliance of 23 projects to 21 CFR 820, 210/211, GAMP 4, and Part 11.
- Implemented document control processes.
- Create a software validation quality system processes of regulated processes.
at this job
IT Quality Consultant
- Collaborated with cross functional teams in determining requirements for product testing.
- Completed test planning including test cases for use by local and offshore teams.
- Worked closely with development and QA teams in disseminating information on upcoming tests via functional document walkthroughs, demonstrations and test plan / test case reviews.
- Work with and support User Acceptance Test teams after completion of functional test execution.
- Defect management duties included follow up with developers to provide information to expedite defect closure.
- Worked in various database instances using SQL queries and forms within Oracle EBS.
at this job
Software Quality Consultant
Performed functional, regression smoke, ad-hoc, mobile, cross browser and data migration testing for Salesforce and Microsoft Dynamics for clients within various segments of the industry. Received Microsoft Dynamics system admin Certification which proved to have a successful track record when testing System Admin tools in Dynamics. Also Tested Salesforce System Admin tools as well.
- Performed SQL Queries to verify and test data migration
- Created and executed detailed test plans and test cases
- Performed Functional, UAT, Integration testing throughout many projects
- Worked in an Agile/Scrum and Waterfall environment (based on clients' needs)
- Took part in stand-up meetings
- Had weekly meetings with the manager to provide updates on projects and provide feedback
- Responsible for update, create, and maintain team documentation
- Hosted Test Plan review meeting with entire project team to ensure the client requirements are being thoroughly met
- Created Test Plans from Functional Specifications Document
at this job
Clinical Quality Consultant
- Provide Case Management to at risk homeless population via HUD grant
- Research and secure grant funding for non-profit partners to assist our community's homeless population
- Provide quality consultation as a clinical expert
- Partner with health care organizations and local businesses to assess and improve quality outcome and effective cost utilization of resources
- Conduct facility audits to ensure partner compliance with all regulatory agencies
- Collect, analyze and develop action plans using six-sigma methodology and communicate findings stakeholders
- Develop process maps, clinical pathways, policies, procedures and training manuals to ensure alignment with organizational goals and regulatory guidelines
- Provide onsite team training on compliance, policies, procedures, team building, quality tools and 5s implementation.
at this job
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