MEUNDA N. WILLIAMS
Germantown,MD
Summary
To continue excelling at Change Management prcoesses by helping to plan, implement, and manage changes within IT service management (ITSM) and to continue the success within an organization.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Cyber Security Administrator / Change Request Manager
Astrion
09.2019 - Current
- Facilitates communication between stakeholders to achieve program objectives.
- Facilitated discussions with Customer and PMT to address dynamic priorities for the Configuration Control Board.
- Perform quality assurance and control for upcoming change requests (CRQ) in BMC Remedy Service Management System. Transition to ServiceNow and
- Tracking and distribution of meeting minutes and acton items.
- Managed the scheduling of conference calls through MS Teams.
- Developed and distributed meeting agendas.
- Facilitated the review and logging of change requests.
- Conducted thorough review of change request documentation to confirm completeness for configuration change approval.
- Managed tracking and status updates for configuration change requests.
- Monitored progress and reported status of CCB team action items.
- Managed SharePoint postings for CCB documentation and data.
- Contributed to the creation and quality assessment of customer documentation.
- Streamlined administrative processes to enhance productivity.
Senior Quality Assurance / Regulatory Associate
Biotech Laboratories U.S.A. LLC
03.2019 - 08.2019
- Prepared regulatory documents for USDA submissions; ensured compliance and monitored guidance from APHIS, CVB, and NCAH.
- Coordinated information from internal and external sources effectively.
- Drafted responses to CVB on production outlines, validation reports, licensing plans, protocols, and APHIS forms.
- Met expectations for study report submissions to CVB while conducting quality checks for consistency.
- Filed and maintained applications with CVB for product submissions.
- Managed staff as needed.
- Reviewed manufacturing records for accuracy and compliance with internal procedures.
- Approved deviations, non-conformances, document changes, CAPAs with management authority.
- Provided compliance guidance to site regularly.
- Responded to quality issues, ensuring timely closure of investigations.
- Served as primary contact for customer inquiries and complaints, facilitating prompt resolutions.
QA Document Control Specialist / Manager
Sanaria, Inc.
12.2017 - 02.2019
- Oversee all aspects of document processes at Sanaria including initiation to archiving.
- Create or update SOPs as required.
- Manage documentation related to SOPs, production procedures, testing protocols, specifications, reports, policies, and lab logs for cGMP compliance.
- Facilitate document management through Excel spreadsheets until eDMS is adopted.
- Maintain and update various tracking logs for Document Control using Excel.
- Deliver training sessions on documentation practices and management procedures across the company.
- Effectively manage label control and distribution tasks.
- Coordinate with Validation Engineers and Senior Management during new facility construction ensuring comprehensive evaluations of affected processes.
QA Focal/Analyst
IBM Corporation
01.2017 - 12.2017
- QA Focal Point for IBM, supporting GxP compliant cloud environments.
- Delivery QA and Compliance for Life Sciences Cloud, Watson Health Implementations to support Infrastructure Qualifications.
- Knowledgeable in cloud computing concepts and architectures.
- Edit and track changes in quality document management systems using QDMS, Opentext, IBM Connections Cloud, Box, and Wiki pages.
- Verify technical documents against requirements through architectural builds for validated environments.
- Effectively interact with clients to rectify errors and modify data.
- Ensure accuracy of test scripts, discrepancy forms, user acceptance tests, and other documentation.
- Review CAPAs and perform Root Cause Analysis for qualified environments.
- Evaluate Validation Plans, Summary Reports, Change Requests, Requirements Specifications, Configuration Specifications, and Test Plans.
- Ensure users adhere to correct procedures and methodologies.
- Collaborate cross-functionally with Project Managers, QA Architects, and Testers.
- Maintain compliance criteria through SOPs and appropriate documentation.
- Provide QA assessments during design and throughout delivery testing phases.
- Offer expert consultation in Life Sciences regulation and Good Documentation Practices.
- Participate in creation and review of GxP project documentation for compliance and audit readiness.
- Ensure quality adherence to GxP requirements and processes.
QA Documentation Specialist III
Novavax, Inc.
06.2016 - 11.2016
- Interacted directly with internal/external stakeholders on a routine basis.
- Support development projects for RSV and Zika.
- Execute routine programs and processes in compliance with incorporated written standard operating procedures and relevant GxP regulations.
- Process manager for all controlled documents to support GxP functions in creating documents, coordinating workflows and overseeing collaborative reviews in eDocument Management System – QUMAS DocCompliance.
- Participated in developing and writing SOPs along with templates/forms management.
- Document/Workflow Coordinator - GMP manufacturing batch records, SOPS, Global Polices, Work Instructions, etc.
- Performed initial quality assessment of new systems and processes implemented.
- Issuance/Review of controlled records (Master Batch Records/Test Method Records and Protocols).
- EDMS Trainer for QUMAS DocCompliance and eDMS Consultant.
QA Document Specialist II
MedImmune
06.2009 - 06.2016
- Provide guidance in analysis through driven projects (DMAIC) in operational excellence while also using Risk Analysis (i.e. fishbone diagram, gap analysis tools).
- Review of reports and data for resolution of audit findings and preparation of reports detailing corrective actions.
- Knowledge and experience with preparation of data visualizations (flowcharts, pivot tables/charts).
- Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system.
Education
Bachelor of Business Administration - Business Administration – Management
Strayer University
Rockville, MD06.2011
Technical Diploma - Network Information Technology
Brightwood College
Beltsville, MD03.2004
Music – Vocal Performance
Virginia State University
Petersburg, VA12.1998
Certification
- Operational Excellence, Lean Six Sigma –
- Yellow Belt Certified – March 2010 (certified thru MedImmune)
- HIPAA certified – July 2017 (certified thru IBM Corporation)
Accomplishments
- Reconciled 5000+ IPs (intellectual property) to meet corporate standards/policies of records management and compliance in Project Management of Laboratory Notebook Compliance and providing monthly metrics.
Timeline
Cyber Security Administrator / Change Request Manager
Astrion
09.2019 - Current
Senior Quality Assurance / Regulatory Associate
Biotech Laboratories U.S.A. LLC
03.2019 - 08.2019
QA Document Control Specialist / Manager
Sanaria, Inc.
12.2017 - 02.2019
QA Focal/Analyst
IBM Corporation
01.2017 - 12.2017
QA Documentation Specialist III
Novavax, Inc.
06.2016 - 11.2016
QA Document Specialist II
MedImmune
06.2009 - 06.2016
Bachelor of Business Administration - Business Administration – Management
Strayer University
Technical Diploma - Network Information Technology
Brightwood College
Music – Vocal Performance
Virginia State University