Natasha Withers

ac134d@r.postjobfree.com *** Connington Way, Rolesville, NC 27571 919-***-****

Career Summary

As a Senior Quality Control Analyst, I am responsible for planning, auditing, developing, documenting and implementing a quality framework for processes and associated training materials for Interactive Response Technology (IRT) and Electric Data Capture (EDC) systems. I also have experience as a Quality Control/Assurance Auditor. I have performed internal and external audits for validating clinical software, vendors and clinical sites. I have developed and delivered process improvement and quality training to associates and team members for corrective actions from audit findings. I also experience in Project and Change Control management, Data Management and Business Analysis.

Project Summary

Clinical trial Quality implementation projects- 2015, 2016, 2017

Software implementation project- LabCorp- 2014

Clinical trial Data Base projects- INC Research- 2012, 2013

Data Migration project- INC Research- 2011

Education

Master of Project Management, Western Carolina University, August 2003

Bachelor of Science in Food Science, North Carolina State University, May 1996

Certifications

Quality Auditor Certification (CQA), ASQ, Certification No: 65942, Expires: June 30, 2019

Quality Engineer Certification (CQE), ASQ, exam date February 2018

Six Sigma Green Belt Certification, ExpertRating- Transcript ID: 2843402, August 2014

Business Analyst Certification, ExpertRating- Transcript ID: 2843403, August 2013

Experience

January 2017- June 2017 Y-Prime Raleigh, NC

Senior Quality Control Analyst

Perform internal and external audits

Manage creation of deviations and initiation of Corrective Actions Preventive Actions (CAPAs) process

Ensure resolution of auditing findings through close collaboration with business partners, stakeholders and vendors

Have knowledge and understanding of current business trends, applicable regulations and quality principals to collaborate effectively and influence approaches to quality and ensure expected work products and output are aligned with regulatory guidelines, ICH-GCP, applicable regulatory requirements and global quality standards

Review documentation for Change Controls, Project Communication Plans, Data Transfer Specifications, other Specification documents and (Installation Qualification)IQ for Valuation, User Acceptance Test (UAT) and Production environments

Provide compliance and investigative support for Good Clinical Practices (GCPs) activities

Conduct risk assessment meeting

Review dummy and production Randomization and Drug lists upon receipt

Perform study randomization checks to confirm each system conforms to the randomization list and specification as expected, post initial subject randomization and at other defined randomization thresholds

Perform computer system validation documentation reviews for initial release of the systems

Develop quality training materials

Train project team members on applicable procedures and documentation

Mentor and train junior-level team members in QC functions

Present ways to make processes more efficient and innovative, based upon metrics

Write departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), Job Aids and Guidelines

Track and trend success of new and updated procedures

Monitor Key Performance Indictors (KPIs) based upon risk assessments

Represent the quality group as a validation/compliance SME, within cross-functional teams

Support product and project teams with implementation of regulatory compliant systems

Define and gather metrics as required

April 2015- January 2017 PAREXEL International Durham, NC

Functional Quality Lead II, Project Quality

Represents Quality Management at audits, inspections and client assessments, including preparation, conduct and follow up.

Perform internal and process audits

To prospectively identify critical quality risk factors and potential impact.

Develops and delivers training for operational staff per the functional curricula to support their roles

Develops job aids for best practices for Departmental and Operational processes

Perform quality assessments (quality gates, gap assessment, study file review) and provides feedback and results to the operational teams as appropriate

Coordinate and execute Quality activities identified in risk management/mitigation programs to validate the systems and processes established to ensure subject safety and protection and to ensure clinical trials are performed and data are generated in compliance with GCPs.

Perform Root Cause Analysis to determine if a CAPA is needed

Determine local quality training requirements that comply with the corporate Quality Management System (QMS)

Facilitate reporting, handling and follow up of Quality Issues

Research and advise on relevant regulatory and industry trends an initiatives to ensure company stays current on GCP compliance issues

Develop quality project plans for assigned projects

Investigate internal quality issues and audit processes to provide suggestions for process improvement and risk mitigation

January 2014- April 2015 LabCorp Morrisville, NC

Business Analyst

Provided analysis to support turnaround time improvement initiatives.

Assisted with business cases and process analysis for the clinical lab and its systems

Designed new processes by analyzing requirements and Key Performance Indicators (KPIs)

Monitored project progress by tracking budget activity, resolving problems; publishing progress reports; recommending actions.

Led process improvement projects

Prepared UAT plans and test scripts for specimen management applications

Developed and maintain project plans, activity logs, meeting agenda and meeting minutes

Constructed workflow charts and diagrams, studying system capabilities, and writing specifications

Planned and monitored daily operations

Prepared technical reports by collecting, analyzing, and summarizing information and trends.

Elicited requirements for process improvements

Managed and communicated requirements

February 2012- May 2013 INC Research Raleigh, NC

Technical Data Manager

Reviewed and author the requirements of study-specific Clinical Data Management Plans for assigned project(s)

Gathered requirements for data management projects

Presented data management finds to all stakeholders

Participated in and presents at internal, customer, third-party and investigative meetings

Managed, implemented and developed documentation for the Change Request process.

Developed and conducted training associated with the Change Request process.

Developed User Test Plans for data entry screens, electronic edit checks, data listings, import/export programs and medical coding

Prepared test data for data entry screens and edit checks

Developed data sets using Clinical Data Interchange Standards Consortium (CDISC) variables and Analysis Data Model (ADaM) standards

Coordinated and supported release of tested clinical data databases to the production environment

Developed and/or delivered electronic Case Report Forms (eCRFs) training for CRAs and site staff and applicable data management departmental training related to technical processes and systems

Developed and maintained CRF and eCRF Completion Guidelines (in consultation with clinical/customer team)

Developed specifications for listings and summaries (other than for statistical reporting requirements) form CRF databases, and external data sources

Designed eCRF entry screens and associated database design for Data Entry guidelines, configurations of CRF Work Manager and SAS Mapping, from Clinical Data Management System (CDMS) Databases

Assisted in the negotiation and contracting process with outside vendors such as eCRF/Diary vendors, CRF printer and Interactive Voice Response System (IVRS) vendors

Maintained documentation on an ongoing basis and ensures that all filing is up to date

Participated in the development of departmental technologies, SOPs, processes and procedures

Trained and mentor data management staff

Contributed to the Request for Proposal (RFP) and Request for Information (RFI) process

Prepared input for and participate in proposal bid defense meetings

August 2008- February 2012 INC Research Raleigh, NC

Operational Support Analyst II

Served as lead on validation projects, communicating project status and key timelines to appropriate associates

Gathered system requirements for data migrations and system validations

Performed internal and external system and database audits

Supported clinical applications, dashboards and web portals

Provided tier 1 and 2 customer service support for clinical applications

Maintained all appropriate testing and validation records and produces reports- Gap Reports, metrics reports and Trial Reports (a type of Crystal Report) for large data sets as needed

Acted as Subject Matter Expert (SME) for an in-house Clinical Data Management System (CDMS)

Maintained associated database design for Data Entry guidelines and configurations of CRF Work Manager and SAS Mapping, from CDMS Databases

Wrote test cases for UAT for applications and server migrations

Wrote SOPs and WIs, and Job Aids (JAs) that are implemented during the Change Request process.

Planned and lead team meetings in the Project Management Office (PMO)

Wrote and edit departmental SOPs, WIs and Job Aids

Performed the role of liaison between end users and IT support teams while maintaining the interests of end users

Proactively communicated to management accurate estimates on time to complete tasks, availability to take on new assignments and resource conflicts

Wrote requirements for systems development, including systems reports

Assisted in the training and mentoring of new Associates, following the Associate’s training plan

Assisted in system testing, system documentation, and process improvement initiatives

Contributed to the project team by suggesting conventions and process

Prioritized project responsibilities and activities in accordance with group or department plans and needs

Monitored incoming communications and responds to sender in accordance with established guidelines

Demonstrated customer-oriented communication skills by responding to end-user, management, and team promptly and within agreed upon timeframes, utilizing appropriate method of communication based on urgency and type of information being communicated

June 2006- April 2008 Novella Clinical Morrisville, NC

Quality Control Auditor

Acted as CAPA lead for quality issues within the Data Management team

Performed 3rd system vendor audits

Provided final Quality Control validation of all study documents and other client documents (e.g., database QC, data management specifications, SAS output, tables, listings and figures) before they are delivered

Was responsible for quality control processes relation to customer deliverables

Provided Quality Control support for the Biostatistics, Clinical Programming, Data Management, Information Technology, and SAS programming groups

Wrote test cases/test scripts to validate clinically-based software

Performed UAT on clinical software (EDC- InForm, Clin Trial, and Medidata)

Worked with department heads in training employees of current GCP,ICH and FDA guidelines and regulations

Managed the Change Control process for Clinical Trial study changes.

Other positions:

Laboratory Associate, FHI 360, October 2003- June 2006

Sr. Laboratory Technician, FHI 360, June 1996- September 2003

Skills

Project and Change Management

Data Management

Business Analysis

Risk Management

Quality Training and Auditing

Reference provided by request

CFR 21 Part 11

Business/Technical Writing

Medical Devices

EU Regulation 536/2014

EDCs- Rave, Inform, OC

GxP (GCP, GLP, GMP)

Implementation Management

ISO 9001

Root Cause Analysis

Trial Master File (Live Link, Vault)

Contact this candidate