Pamela Simone

63 Swearingen Way
Shepherdstown, West Virginia
Home: (301) 606-7610
ps8a8308@westpost.net
Experienced with biologics, in vitro diagnostics, pharmaceuticals, and medical d
evices manufacturing operations. Experienced with CFR 21 Part 11, GLP and GMP, S
ix Sigma, ISO certification, and European regulations. Strong problem identifica
tion and resolution skills. Experienced with CAPA initiation and implementation,
process gap analysis, action plan development and remediation, large-scale proj
ects, and leading small work groups. Ability to work with minimal supervision, a
dhere to corporate, local and project policies and procedures. Lead and coordina
ted activities in receiving inspection, product release and document control dep
artments, and validation teams.
Experience
2005-2009 MedImmune Frederick, MD
Compliance Specialist
Applied Six Sigma to product complaints metrics project that reduced complaint c
ycle time by 35%
Coordinated TrackWise report development to track product complaint investigatio
n metrics for on-going process improvement
Managed all complaint investigations coordinating all sample evaluations and pro
duct lot history review across multiple sites and departments assigning related
tasks and investigation activities to site investigators
Prepared all investigation reports summarizing investigation results and correct
ive actions (if applicable) that resulted in complaint resolution and process im
provements that resolved complaint trends
Prepared weekly, monthly, quarterly reports that included trending evaluations a
nd CAPA activities on active complaints
Coordinated and prepared annual product review of complaint activities, trends,
and analysis of CAPA activities related to complaints
2004-2005 Morton Grove Pharmaceuticals, Inc. Chicago, IL
Product Complaint Coordinator
Prepared all investigation reports and response letters to complainants summariz
ing investigation results and corrective actions (if applicable) to resolve comp
laints
Prepared all MedWatch reports and follow-up investigation updates to the FDA
Received and logged all complaints into the complaint system
Coordinated corrective and preventative actions with the CAPA Coordinator to res
olve complaint trends that resulted in changes to products or processes
Prepared all response letters to clients summarizing investigation results and c
orrective actions (if applicable)
Prepared weekly, monthly, quarterly reports that included trending evaluations a
nd CAPA activities on active complaints
Coordinated and prepared annual product review of complaint activities, trends,
and analysis of CAPA activities related to complaints
2003-2004 CTG Contractor to Eli Lilly Greenfield, IN
Validation Lead and Acting QA Manager
Lead validation team that included direct and non-direct reports that analyzed v
alidation needs for GCP compliance of equipment used in new product development
Prepared and coordinated approval and acceptance of validation documentation for
laboratory testing systems (flow cytometers, spectrophotometers, microplate rea
ders, scanning electron microscope, etc.)
Coordinated validation activities with client representatives
Managed and updated Validation Team internal documentation
Chaired QA Team meetings and coordinated QA Team activities
2000-2003 Cardinal Health St. Petersburg, FL
Product Complaint Specialist
Investigated all complaints including batch documentation and production records
review, coordinated testing of samples, and coordinated related activities rela
ted to investigations
Prepared investigation reports and CAPA recommendations based on complaint trend
ing analysis
Prepared all response letters to clients summarizing investigation results and c
orrective actions (if applicable)
Received and logged all complaints into the complaint system
Developed and maintained all related documentation for complaint tracking and in
vestigations
1999-2000 Technical Writer (contractor) Mason, OH
Contracted with GE Industrial Systems (Manpower) CNC and CNN equipment; Interna
tional Paper (Belcan) Automated aseptic filling and packaging equipment; Westva
co (Manpower) Paper manufacturing; Buschman Company (Belcan) Automated conveyo
r systems; Makino (MBS Associates) CNC and CNN equipment; Ryder Transportation
Systems (independent) Logistics Technical Writer
Successfully updated procedures to current ISO9000 and company standards to meet
customer requirements
Prepared and transferred documents and forms to on-line electronic publication
1997-1999 Vickers Electronic Systems S. Lebanon, OH
Technical Writer
Prepared and coordinated approval of user manuals for automated manufacturing sy
stems
Coordinated all ISO 9002 compliance for the Technical Training and Publications
department that resulted in successful certification
Worked with Research and Development to troubleshoot pre-release software
1996-1997 Dentsply International Encino, CA
Document Control and Regulatory Affairs Coordinator
Managed document control department ensuring accuracy and compliance of sales an
d marketing, legal, product documents, policies and procedures, and product labe
ling
Researched, developed, and conducted GMP and ISO9001 training programs that resu
lted in successful audits and ISO certification
Provided liaison and managed all third party and internal audits that consistent
ly maintained compliance and licensee status. Coordinated all corrective actions
related to audit results
Managed ISO-9000 program that resulted in successful facility certification
1992-1996 Diagnostic Products Corporation Los Angeles, CA
Document Control Supervisor
Established and managed document control department that provided consistent doc
ument approval and release, eliminated duplicate numbering of documents, reduced
recording errors, and centralized all document control functions
Supervised Document Control and Product Release personnel
Used document control to implement corrective actions and update to current GMP
and ISO 9001 compliance that resulted in successful documentation audits by ISO
and regulatory agencies
Active in all facility internal and third party compliance audits that resulted
in facility compliance to regulatory requirements
Participated in ISO9001, GMP, and document change training that ensured complian
ce to regulations and procedures
Participated in validation studies for processes and products to ensure complian
ce to regulatory requirements
Computer Skills
Microsoft: Word, Excel, Power Point, Project, Access, and Outlook
Adobe: FrameMaker, Illustrator, PageMaker
Other: TrackWise, Citrix, Interleaf, Corel Draw, Minitab, Quality Companion
Education
California State University, Fullerton, CA; Degree: BA in English
Cincinnati Technical College, Cincinnati, OH, Degree: AA in Business Administrat
ion
Certification
Six Sigma Green Belt (Six Sigma.US)