Quality Testing
Resume:
Tanisha B. Sutton
Raleigh, NC 27610
**.******@*******.***, 919-***-****
PROFESSIONAL SKILLS
Superior analytical, troubleshooting, communication and presentation skills
Strong background in all phases of Microbiology/Biology/Chemistry/Genetic Engineering research and lab work
Deviation Assessment and Reporting
CAPA Reporting
Method Validation and Bio-burden Testing
HPLC, Western and Southern Blot testing,
Use of auditing and inventory control
GMP/GLP/GCP compliant
Creation of documentation for implemented processes
LIMS implementation
Training of personnel
Member of management team which managed a total of 15-20 people
CAREER HISTORY
KBI Biopharma Durham, NC
Quality Specialist I 4/16/2014 - Present
Performs compliance review on the following records: batch record (includes on-the-floor review of records); release data, method qualification/validation reports, and development reports.
Reviews and approves Master Batch Records and Solution Records
Works directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
Reviews the following equipment-related documentation; qualification protocols and final reports, master specifications and out of calibration reports.
Participation and support of client project teams and regulatory audits.
Conducts internal audits of departments involved in GMP activities and provides guidance for corrective actions.
Approval and Rejection of incoming raw materials and products for use in manufacturing
Review and approve change controls and specifications.
Able to react to change productively and handle other essential tasks as assigned.
Evaluating deviations, laboratory investigations, and customer complains which may impact quality
Ensuring QA Reserve samples are collected, stored, and inspected as required.
Ensuring that storage and shipping conditions for materials and products are defined and monitored
Ensuring that product has been produced, tested and checked with appropriate quality standards (including cGMP, regulatory filings and customer requirements) governing the testing of the material.
Provided and executed process changes for release and use of incoming products and raw materials
Sample/Stability Coordinator 8/26/2013 – 4/16/2014
Packing and shipping of outgoing samples to clients
Creation of Labels and Logging in of incoming samples from clients
Pulling and Staging of Stability Studies
Executed the reorganization and cataloged client samples for use
Compiling of GMP Worksheet Packets for Stability, Specifications and Manufacturing Data Packets and reissue of Worksheets for failed testing, etc.
Tanisha B. Sutton
4001 Patriot Ridge Ct.
Raleigh, NC 27610
**.******@*******.***, 919-***-****
Almac Clinical Services, Durham, NC 10/24/2011 – 6/10/2013
Quality Systems Coordinator
Responsible for the management of the Durham site Livelink, Trackwise, and DocGen systems
Managed and monitored the fileplan to ensure correct usage within Livelink
Worked with team members to implement the use of COSMOS
Perform validation activities to support the release of new systems/change of existing systems into operational use.
Perform gap assessments against new and revised Quality Modules, Quality Directives and SOPs at the site comply with the requirements of Almac's Quality Manual and meet all relevant cGMP and regulatory requirements.
Assist with development and/or revision of Quality System procedures and processes
Durham Technical Community College, Durham, NC 7/2011 - 10/2011
Teacher
Instructor of Career Readiness class (Provided in depth teaching of Science, English and Resume writing)
Instructor of Bioworks (In depth teaching of Aseptic technique, Gowning Certification and GMP Environmental training)
Novartis (ManPower), Holly Springs, NC 4/05/2010 – 6/28/10
Microbiologist I
Assist with site start-up activities
Perform both routine and non-routine environmental monitoring to include viable and non-viable air monitoring, surface monitoring, facility gas monitoring an facility water collection
Perform water testing assays such as TOC, conductivity, endotoxin and bioburden
Adecco, Durham, NC 2/02/09 – 5/08/09
Microbiologist Technician
Environmental Monitoring of airborne particles and microbial analysis of plant air
Microbial Analysis of Plant Water
Mouse Embryo and Tissue Culture sample preparation for testing
Talecris, Clayton and Durham, NC 6/00-10/17/08
Quality Supervisor 7/30/07 – 10/17/08
Assure all plasma shipments meet specifications and requirements as defined in the Donor Center Standard Operations Procedures manual
Assure that samples shipped to the testing laboratory are correctly and accurately labeled and documented
Assure that all center incidents are properly documented. Trend and follow-up on incidents/errors as required and report on incident trends in monthly staff meetings
Assure that information in the donor record files are complete and accurate
Assure that supplies and materials meet requirements
Assure that equipment is properly maintained and calibrated. Assure documentation of equipment maintenance and calibration is accurate and appropriately filed
Corrective Action Preventive Action reporting (ex. MIRs or Deviations)
Tanisha B. Sutton
4001 Patriot Ridge Ct.
Raleigh, NC 27610
**.******@*******.***, 919-***-****
Quality Associate II 8/30/04 – 7/30/07
Performed Audit of in-house plasma pools
Plasma Pool Reconciliation for internal and external pools
Monitored, Review and changed circular charts on freezer 13AR01 weekly for storage of Plasma pool samples
Verification of units listed on Notification for Destruction of Plasma (NDP’s)
Audit and Release of Plasma Vendor Batches and Pools
Corrective Action Preventive Action reporting
Associate QA Biologist 6/00 – 8/30/04
Performed environmental monitoring testing air for viable and total particulates
Performed plating of swabs for production areas
Collected water samples for LAL testing; Microbial testing using the filtering method
Performed collection of Nitrogen gas and compressed airs for moisture testing and microbial testing
Testing of final products and raw materials for the presence of bacteria endotoxin using the gel clot method
Performed collection of steam for Microbial and LAL testing by use of CWFI method and Ice Bath Method
Testing of washed bottles to monitor for microbial growth
Performed testing of Raw Materials
Performed calibration of RCS air samplers
Collection and Testing of Biological Indicators for the presence of any contaminants for cleaning validations
Performed method validation testing of bio-burden samples
Microbial and LAL testing for stoppers for the presence of bacteria
Creation, revision and review of Standard Operating Procedures
Perform non-routine testing associated with validation protocols, critical changes, engineering test plans, and non-routine work requests
Training of New employees
EDUCATION
Bachelor of Science in Biology – May 2000
Minor-Chemistry
South Carolina State University, Orangeburg, SC
Masters in Business Administration – December 2004
University of Phoenix, Phoenix, AZ
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