Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Keyda Jones

Atlanta,GA

Summary

Quality Assurance professional with over 24 years of experience in Cell Therapy, Biopharmaceuticals, Biotechnology and Biologics, offering expertise in the areas of Quality Management and Quality Systems. Distinctive Qualifications Self-Motivated Excellent Verbal and Written Skills Proficient in MS Office Outstanding Mentor, Leader and Trainer Electronic Quality Management Systems (eQMS) Administrator Strong Problem-Solving, Issue Resolution, Root Cause Analysis and CAPA Management skills cGMP (Current Good Manufacturing Practice) GTP (Good Tissue Practice) GCP (Good Clinical Practice) GLP (Good Laboratory Practice) Proficient in Internal and Vendor GXP Audits

Overview

16
16
years of professional experience
1
1
Certification

Work History

Supervisor, Manufacturing Quality Assurance (MQA)

Dendreon Pharmaceuticals
Union City, GA
10.2019 - 02.2024
  • Responsible for the Quality Operations management of the commercial manufacturing of cell therapy Provenge (Sipuleucel-T) product which is manufactured in a clean-room environment using the patient’s blood, personalizing the treatment
  • Kept senior management apprised of all situations and emerging trends; including attendance, productivity, efficiency, disciplinary issues and staff motivation
  • Directed day-to-day departmental activities of line staff, resolved issues and set departmental priorities
  • Measured departmental performance with respect to quality and compliance requirements
  • Responsible for product disposition decisions of all nonconforming products
  • Served as Subject Matter Expert (SME) by maintaining a high level of expertise in local Standard Operating Procedures (SOPs) and current regulatory requirements and applied knowledge for daily decisions
  • Reviewed and approved GMP Controlled documents including SOPs, Work Instructions, Protocols, Equipment Validations and Test Methods
  • Responsible for ensuring that an appropriate root cause investigation had been performed for complaints, as well as determined whether the complaint was associated with an adverse event
  • Reviewed and approved Deviations, Nonconformances, Root Cause and CAPA investigations, evaluations, assessments against regulatory requirements/standards, risk assessments, procedures, and change controls
  • Reviewed Deviation, Nonconformance, and CAPA documentation for completeness, correctness, and concurrence prior to closure
  • Conducted training on Deviations, Nonconformances, Root Cause Investigations, and CAPA management and executed within the eQMS
  • Represented the department in cross-functional teams and GXP related problem resolution
  • Partnered with colleagues in other departments to problem-solve, address complex issues and execute CAPAs
  • Coordinated and collaborated with cross-functional teams to meet organizational goals and work requirements
  • Collaborated in the continuous improvement of processes, identified opportunities and led them through the implementation
  • Performed aseptic gowning for Quality Observations within ISO controlled Clean Room Environments
  • Responsible for authoring SOPs, Work Instructions, and Training Quizzes within the Learning Management System (LMS)
  • Responsible for the development of monthly Quality Metrics for Quality Council meetings.

Senior Quality Specialist

Dendreon Pharmaceuticals
Union City, GA
03.2013 - 10.2019
  • Configuration and Administration of the Electronic Quality Management System (eQMS)
  • Qualified Lead Auditor on GTP Supplier Audits of Apheresis Collection Sites
  • Performed commercial and clinical batch record preparation, issuance, and batch record review
  • Performed commercial and clinical batch record closure
  • Ensured the quality and compliance of clinical trial for early stage cancer treatment conducted throughout Dendreon Immunotherapy Manufacturing Facilities (IMFs)
  • Worked cross functionally with internal and external customers in support of Clinical Quality Assurance (CQA) initiatives to ensure continuous improvement and quality adherence to agency regulations and standards, GCP, industry guidelines, and Dendreon policies and procedures for the conduct of clinical trials
  • Performed QA review of Impact Investigations to determine commercial and clinical product’s acceptability for disposition and shipment
  • Performed issuance of controlled labels and forms
  • Reviewed and approved GCP/GMP controlled documents including SOPs, Batch Records and Test Methods
  • Ensured full GCP/GMP compliance for the disposition of raw materials and components
  • Tracked and trended Nonconformances, corrective and preventive actions, Out of Specifications (OOS), investigations and other metrics in support of management review
  • Provided support in the following: Investigation and recall of non-conforming materials
  • Investigations associated with product failures, product complaints and BPDRs
  • Reviewed Nonconformance details or Deviation documentation for completeness, correctness, and concurrence prior to closure
  • Completed Risk Assessments for all Nonconformances to assess the risk based on the determination of Severity, Occurrence and Detection
  • Managed Nonconformances to ensure investigations are closed within the specified time period
  • Implemented Corrective and Preventive Actions based on the root cause(s) identified
  • Represented the department in cross-functional teams and GXP-related problem resolution
  • Performed aseptic gowning for Quality Observations within Clean Room Environments
  • Communicated daily with area Subject Matter Experts in order to review non-conformances and CAPAs
  • Performed and supported Quality on the Floor to ensure company-wide compliance to quality system standard.

Quality Assurance Auditor

Quintiles
Marietta, GA
08.2011 - 03.2013
  • Planned, conducted and reported assigned quality assurance audits
  • Supported management in promotion and assessment of compliance to regulations, guidelines and corporate policies
  • Provided quality assurance oversight under the direction of senior QA staff through interaction with customers, project and study teams and associated Quintiles functions
  • Conducted Clinical Quality Assurance activities and projects for clients according to Quintiles departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits
  • Assisted operations in preparation and review of CAPA plans
  • Represented quality assurance program on customer and project teams
  • Documented and reported quality and compliance issues to QA management according to required timelines
  • Advised quality assurance management on system audit needs
  • Hosted or assisted in hosting Customer Audits, Mock Regulatory Inspections and Regulatory Facility Inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed
  • Lead Auditor for Internal Audits and Vendor Audits
  • Assisted in preparation and review of corrective action plans associated with customer audits
  • Enhanced and maintained a working knowledge of relevant Clinical GXP regulations.

Regional Quality Director

Octapharma Plasma, Inc.
Atlanta, GA
09.2009 - 12.2010
  • Responsible for the interviewing and hiring of Quality staff and ensured adequate center coverage for all regional centers
  • Conducted regularly scheduled staff, safety and quality meetings; ensured that the minutes were communicated to all center staff
  • Prepared for and performed Donor Center internal GTP audits as Lead Auditor
  • Hosted customer audits (FDA, EU and CLIA); worked with the Center Director and Quality Supervisor to complete all audit responses; ensured all audits were responded to and closed in required time frames
  • Supported the operations management in efforts to meet the region and company goals
  • Analyzed tracking and trending data, determined appropriate actions from this analysis to improve the trends
  • Implemented, maintained, and monitored quality systems that would improve quality in the product and services delivered/performed by the donor center and ensured compliance with all established SOPs, cGMP requirements, and other applicable requirements
  • Assisted in the technical writing of any Donor Center SOP creation of forms and/or memos, and provided any other support necessary to implement new/revised SOPs, as needed
  • Investigated and assisted in developing corrective action propels; worked in conjunction with department management to review processes and take appropriate corrective actions that may affect the safety, purity or quality of the product or donor
  • Assisted in the development and review of new and revised GMP operating procedures
  • Monitored compliance of all corrective actions to prevent recurrence and performed checks to ensure effectiveness of actions.

Quality Manager

International BioResources, LLC
Tucker, GA
01.2008 - 09.2009
  • Provided direct supervision of the center Senior Quality Supervisors / Quality Supervisors
  • Provided indirect supervision to Operations management related to QA compliance in the Donor Centers
  • Monitored center quality performance through direct and indirect contact, which included periodic on-site visits
  • Maintained thorough familiarity with all customer and regulatory body requirements including but not limited to State and Federal regulations, EU GMP regulations, OSHA regulations, Clinical Laboratory Improvement Act of 1988 (CLIA) as applicable
  • Supported the center’s ongoing Quality Supervisor training and education through in-service sessions
  • Tracked all internal, customer and FDA audit findings to closure; ensured that FDA audit Corrective Action Preventive Action dates were met
  • Evaluated the adequacy and completeness of Exceptions Reports, using available resources as needed
  • Investigated and proposed additional Corrective Actions as required
  • Monitored center compliance with all applicable regulatory and SOP requirements
  • Assisted and directed the development of Corrective Action Preventive Action Plans and Effectiveness Checks
  • Participated in ongoing internal, customer and regulatory audits of donor centers
  • Ensured adequate preparation of Quality Supervisor staff to participate/host audits
  • Assisted with ensuring that operating procedures were written at the appropriate user level
  • Assisted with the development and integration of new/revised SOPs upon implementation
  • Supported the company’s training goals through development of training materials for SOPs or other training initiatives as determined by Executive Management
  • Evaluated center systems to ensure best practices that would drive and sustain compliance.

Education

M.B.A. Management -

Strayer University
12.2005

B.S. Biology -

Francis Marion University
12.1996

Skills

  • Self-Motivated
  • Excellent Verbal and Written Skills
  • Proficient in MS Office
  • Outstanding Mentor, Leader and Trainer
  • Electronic Quality Management Systems (eQMS) Administrator
  • Strong Problem-Solving, Issue Resolution, Root Cause Analysis and CAPA Management skills
  • CGMP (Current Good Manufacturing Practice)
  • GTP (Good Tissue Practice)
  • GCP (Good Clinical Practice)
  • GLP (Good Laboratory Practice)
  • Proficient in Internal and Vendor GXP Audits

Certification

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), 04/01/2023, CITI Program Online

Timeline

Supervisor, Manufacturing Quality Assurance (MQA)

Dendreon Pharmaceuticals
10.2019 - 02.2024

Senior Quality Specialist

Dendreon Pharmaceuticals
03.2013 - 10.2019

Quality Assurance Auditor

Quintiles
08.2011 - 03.2013

Regional Quality Director

Octapharma Plasma, Inc.
09.2009 - 12.2010

Quality Manager

International BioResources, LLC
01.2008 - 09.2009

M.B.A. Management -

Strayer University

B.S. Biology -

Francis Marion University

Similar Profiles

CREATE PROFILE
Keyda Jones