Manager Quality Assurance
Resume:
Chanell Monsegue
Houston, TX 77077
Cell: 832-***-****
***********@***.***
Skills Summary
Self-starter, detail-oriented, dependable and willing to meet any
demands of the job. Working experience in various areas of GMP,
GLP, and GCP with biologics, drugs, and dietary supplements.
Experience
Biotics Research Corporation 6/08 -
Present
Quality Assurance Manager
Develop, implement, and maintain SOPs for oversight of the
manufacture, testing, and release of dietary products.
Review and approve master batch records, raw material and product
specifications, and analytical procedures.
Develop and implement Quality Systems as necessary to maintain
compliance to cGMPs.
Review and approve executed batch records for finished products
and issue C of As.
Perform/Coordinate investigations related to OOS results and
product complaints.
Oversee the vendor qualification program.
Conduct annual cGMP training for employees.
Perform Quality audits of contract testing laboratories and raw
material vendors as needed.
Perform internal audits on various departments as necessary.
Prepare and submit applications to regulatory agencies (FDA) as
needed.
Liaise with other department Managers to ensure CAPAs are
implemented in a timely manner.
Cogenics 01/07 - 06/08
Validation Specialist II
07/07 - 06/08
Work with the Validation Manager to develop and implement Part 11
Remediation Plans.
Assist the Validation Manager in developing software and
equipment validation documentation.
Interface with laboratory users and IS personnel in the
development of Functional Requirements documentation, IQ/OQ
Plans, IQ/OQ Summary Reports, Validation Test Plans, Test
Scripts, Test Result Analysis, and Validation Summary Reports.
Lead Method Validation Activities for the entire division under
supervision of Validation Manager.
Assist Validation Manager in maintaining the Validation Planning
and Scheduling Matrices.
Assign Property ID numbers and maintain property ID Log and
Master Equipment List for the Houston facility.
Work with Validation Manager to set priorities among validation
projects.
QA Validation Specialist 01/07 -
07/07
Develop and review equipment qualification documentation
(IQ/OQ/PQ).
Assist Validation Manager in developing software validation
documentation
Maintain validation document templates in accordance with
regulatory guidelines
Assist in the validation planning and scheduling matrices
Development, implementation, and maintenance of Quality Systems
Review GLP Study documentation including protocols and reports
Participate in the preparation and coordination of Sponsor and
Regulatory audits
Internal and External Auditing
Oversee Vendor Qualification
Conduct GLP/GMP training
Review all Regulated samples received from the project check-in
area
Approve and Release raw materials
Approve and Release in-house prepared solutions for the
laboratory
SOP Management, Distribution, Approval and Control
Approve deviations and CAPAs
Trending of Quality Systems
Follow up on corrective/preventive actions
Tanox, Inc. 02/05 - 01/07
Quality Assurance Specialist I
07/05 - 01/07
Internal Auditing of Various Departments (GMP, GLP, and GCP)
External Auditing of CMOs
Originator of Vendor Qualification Program (SOP)
Audit GLP and Clinical Studies
Review and Approve Stability Data (Houston and San Diego)
Approval of Quarantined Raw Materials
Review and Approve Assay Validation Protocols/Reports
Review and Approve Development and Technical Reports
Review and Approve Equipment Qualification (IQ/OQ/PQ)
Batch Record Review/Approval
Review/Approval of QC Testing Data
Review/Approval of Environmental Monitoring and Water Testing
Data
Provide cGMP Training for Employees
Release of Production Areas for GMP Material
Issuance of Production Records
Change Control Management and Approval
Follow-Up on CAPA
SOP Management, Distribution, Approval and Control
Approve Deviations and Incidents
Maintain and Organize Records for Archive
Quality Control Analyst I 02/05 - 07/05
WFI, Purified Water, and Clean Steam Water Sampling
Management and Sampling of Quarantined Raw Materials
Conductivity Testing of Water and QC Samples
LAL Gel Clot Testing for the Detection of Endotoxin
Quality Control Sample Management
Organization and Archive of Stability Data
Management of Environmental Monitoring Database
computer skills
Microsoft Word, Excel, Access, and Power Point
Education
MBA Candidate - Concentration in Management 2011
LeTourneau University, Houston, TX
B.S., Forensic Science, Minors in Criminal Justice 2004
and Spanish
Baylor University, Waco, TX
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