Lead Quality Assurance Professional

PROFESSIONAL SUMMARY

Results-Oriented quality/regulatory professional with an MBA in Health Care Management and 16 years of experience in the Healthcare/Biotech/Pharma/Medical Device Industries as a leader, individual contributor and team player. Extensive knowledge of U.S. and Global Quality System Regulations including: GXP, ICH Q7, MDD, JPAL and CMDR. Experienced in Lean/Six Sigma principles, FMEA and root cause analysis. Familiar with CMS, JCAHO, NCQA, HEDIS and CAHPS requirements.

KEY STRENGTHS

Detail Oriented

Quality Driven

Problem Solver

TECHNICAL/SOFTWARE APPLICATIONS

TrackWise® (Sparta Systems)

Pilgrim Smartsolve® (eQMS)

Oracle® ERP

MasterControlTM

Online Product Update System (PantheonSM)

iMIS15 (ASI)

Blue Mountain Regulatory Asset Manager (BMRAM)

LabWare LIMSTM

MS Office

PROFESSIONAL EXPERIENCE

Janssen Pharmaceuticals, contracted through ALKU Quality, Remote 06/2016-03/2017 Quality Consultant-PV CAPA Process Coordinator

Supported management of Pharmacovigilance (PV) CAPA lifecycle activities.

Conducted data entry for approximately 600 quality records (Event/Deviation, CAPAs, etc) into TrackWise, including assurance of data integrity.

Facilitated distribution and transparency for Event/CAPA workflow and management of activities in the lifecycle.

Managed contact with Global key business stakeholders to ensure accuracy and quality of Event/CAPA data.

Monitored and tracked audits/investigations related to PV activities to update Lead Auditors and coordinated schedules for audit/investigation report receipt and review.

Lexicon Pharmaceuticals, contracted through ALKU Quality, The Woodlands, TX 03/2015-04/2016

Quality Consultant-QA GMP Specialist

Supported all CMC functions with review of Clinical Trial Material (CTM) documentation within Contract Research Organizations (CRO), Investigator sites and Depots for multiple programs and studies.

Represented the Quality Unit and attended weekly meetings associated with GMP Investigational Medicinal Product (IMP) for Global Supply Chain.

Managed review, release and filing of GMP documentation/lot traceability projects/investigations for API, drug product, IMP and CTMs.

Ensured specification and parameter compliance of API Process validation bilingual batch records with Global CROs.

Represented the Quality Unit on projects for product lot traceability and Genealogy Reports, to assist with NDA filings in compliance with HIPAA.

Cambridge Major Laboratories, contracted through Oxford Global Resources, Milwaukee, WI 06/2014-01/2015

Quality Compliance Consultant-Batch Record Reviewer

Conducted review and approval of executed batch records for active pharmaceutical ingredients and pharmaceutical intermediates in Validation, Phase I-III and Commercial production.

Reviewed record data and supporting documentation, to ensure compliance with the internal controls per cGMPs and ICH Q7 regulations.

Dendreon Corporation, Union City, GA 08/2011-06/2014 Sr Quality Assurance Associate I-Quality Systems

Monitored and managed Investigations associated with Product Failures, Product Complaints, Biological Product Deviation Reporting System (BPDR) and Recall of non-conforming materials.

Coordinated activities with cross functional departments to provide quality input for Exception Report impact assessments to ensure timely disposition of product.

Assisted with root cause assessments to solve quality compliance issues.

Provided guidance for implementation of corrective actions to prevent delays in product disposition and recurrence prevention.

Assisted with continuous improvement initiatives to improve the control and flow of batch production documentation and quality control data management.

Performed quality approvals of BMRAM to verify completion of scheduled work orders/calibration records/preventative maintenance records for timely closure of CAPA action plans/Exception reports.

Conducted training sessions for all user roles within Pilgrim eQMS.

Provided Quality oversight of operations and data review to ensure conformance with cGMP and quality standards for continuous improvement initiatives.

Represented department in cross-functional teams for inspection readiness, site specific projects, GXP-related problem resolution and continuous improvement initiatives.

National Quality Forum (NQF), Washington, DC 08/2010-03/2011 Quality Assurance Manager-Performance Measures

Managed quality management program to enforce internal quality control/assurance within the Performance Measures (PM) Department to implement continuous quality improvement and efficiency initiatives.

Monitored activities of 30 Consensus Development Process (CDP) and non-CDP projects to ensure adherence to contract guidelines and grant obligations.

Developed and maintained procedures for the use of the Online Product Update System

(OPUS) to implement CDP management tools that control data and activities of the CDP projects.

Conducted and managed audits and assessments to provide management with KPIs on the adequacy and timeliness of the CDP and non-CDP processes.

Investigated and recommended solutions to ensure compliance with Corporate and Departmental procedures in the PM department.

Managed the document control activities on the NQF intranet PM site which stored the PM templates, policies and procedures.

Managed all NQF website postings in coordination with the Communications Department to ensure accuracy and timeliness in accordance with CDP project requirements.

Provided direction and guidance to all levels of the PM department for the implementation of policies, operational guidelines and quality initiatives. Shimah T. Wheatley

DENTSPLY International Professional, York, PA 09/2008-08/2010 Quality Specialist II/CAPA Coordinator

Successfully led the transition of Division's paper based CAPA system into TrackWise®.

Assessed and improved the consistency, quality, and timeliness of divisional CAPA execution through implementing and maintaining effective CAPA monitoring systems, RCA tools and review mechanisms.

Managed Corrective and Preventive Action (CAPA) electronic system (TrackWise®) for two DENTSPLY Divisions producing Class I-III medical devices, in compliance with ISO 13485 standards.

Provided guidance/training for all Business Unit personnel performing activities within the CAPA system by developing and improving SOPs to ensure compliance.

Developed, enforced and participated in continuous improvement measures for Quality Management Systems (QMS) to ensure best practices.

Represented Quality department on successful Corporate, Regulatory body and Notified body audits.

Served as CAPA Review Board (CRB) chair.

Lonza Baltimore, Inc., Baltimore, MD (Formerly Cambrex Bioscience Baltimore, Inc.) Quality Assurance Specialist II, 04/2005-08/2008

Quality Assurance Specialist I, 03/2004-04/2005

Sole QA Specialist that managed 4 successful client campaigns (Research, Phase II, Phase III and commercial) meeting critical project milestones.

Promoted to QA Specialist II after one year of employment based on capabilities and perseverance.

Successfully managed Mammalian Cell Culture, Cell Therapy, microbial fermentation and protein purification client projects, per cGMP regulations for aseptic biological product manufacturing.

Supervised, mentored and delegated responsibilities to quality associates for review of Master Production Records, Batch Production Records, procedures, deviations, ICARs and compliance initiatives.

Contributed to successful client FDA PAI and EMEA commercialization audits.

Executed internal audits and off-site vendor/supplier audits.

Awarded Above and Beyond Award for successfully meeting project timelines prior to forecasted milestone dates for client projects.

Received numerous client awards for exceptional performance.

Osiris Therapeutics, Inc., Baltimore, MD

Quality Assurance Analyst, 11/2002-03/2004

Quality Control Analyst, 02/2001-11/2002

Managed CAPA, deviations, NCMRs, consultant qualifications and the returned goods system.

Key player in the development of the Quality Assurance Training Program focusing on cGMP compliance.

Conducted internal audits, inspection and release of raw material and final product.

Reviewed and approved batch production records, product release records and research/validation/calibration reports and protocols to assure compliance with GXPs and Chemistry, Manufacturing and Controls (CMC) guidance.

Developed and implemented master specification documentation for raw materials.

Contributed to the generation of regulatory IND submissions.

Performed flow cytometry analysis, PCR analysis for the rapid Mycoplasma test, environmental monitoring, sterility and endotoxin testing for raw materials, in-process, and final product to ensure suitability for use.

Reviewed and approved in house and contract lab test data for deviations and OOS/ OOL investigations.

Developed and revised SOPs for QC processes to continuously meet cGMP/GLP compliance.

Executed and monitored aseptic technique for cleanrooms, water systems and cGMP/GLP testing methodologies.

Assisted with QC assay method development/validation, and equipment calibration.

Served as Material Review Board (MRB) Chair.

COMMUNITY SERVICE

CASA Volunteer, National CASA Association 09/2013-2014

EDUCATION AND PROFESSIONAL DEVELOPMENT

MBA-Health Care Management Colorado Technical University, Colorado Springs, CO 2008-2009, GPA: 3.74

B.S.-Biological Sciences Hampton University, Hampton, VA 1996-2000

Professional Certificate, Business Administration-Graduate Level, Colorado Technical University, 2009

Certificate, Root Cause Analysis and Effective Investigation Report Writing, 2006

Certificate, RAPS, Regulatory Affairs: Pharmaceuticals, 2013

ASQ Member

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