Quality Control Six Sigma
Resume:
Tenisia Ransom, MBA
Lawrenceville, GA 30044
678-***-**** (cell)
*************@***.***
www.linkedin.com/in/tenisiaransom
SUMMARY
QA Chemist experienced in analyzing and validating. Develop training programs that contribute to operating consistency throughout the
organization. Solution driven with an emphasis on facilitating change and retaining core standards and integrity. Articulate problem solver
with superior analytical and communications skills.
AREA OF EXPERTISE
Clean Room Training and Development
Instrumentation Validations Developing SOPs
CAPA Equipment Calibration
PROFESSIONAL EXPERIENCE
Ethicon, Cornelia, GA April 2013- Present
Johnson & Johnson/ Kelly Scientific - Contractor
QA- Chemist
• Team Lead over lab analyst
• Manages laboratory operation workflow, oversees laboratory investigations and provides technical assistance to all
team members. Ensures that all safety, cGMP and SOP policies and/or procedures are followed
• Performs qualitative and quantitative chemical analysis of raw materials, monomer, polymer, and suture products.
• Provide test analysis information on the status of conformance to requirements.
• Investigate testing abnormalities and implements corrective action.
• Assist with determination of root causes of non-conformances and recommends corrective actions.
• Audits documentation, device history records, and test methods for compliance.
• Development of new test methods of performing investigative test analysis.
• Validation of test methods and transfer of new products/processes/test methods.
• Coordinates testing, and supports testing validation and transfer.
• Performs Equipment Installation Qualification (IQ’S).
• Performs document changes and validations using the ECCS System.
• Manages projects including test elimination or transfer.
GeoVax, Smyrna, GA Jan 2012- Dec 2012
AIDS Vaccine Research
(Contractual)
Laboratory Manager, Quality Control
• Facilitate classroom training sessions for newly hired associates, utilizing multiple methods to support learning and
retention of Pest service standards, programs and services, in addition to problem solving, interpersonal skills and Ecolab
policies and procedures
• Serve as the Chemical Safety Officer
• Method Validation
• Instrumentation Validation
• Lean/Six Sigma Projects
• Equipment Calibration
• Oversee the GeoVax Biosafety Training Program
• Management of GMP vaccine and QC reagent storage on-site.
• Manage equipment inventory tracking system and maintenance/calibration schedule
• Organize and improve efficiency of laboratory operations and procedures.
• Perform Quality control release and stability testing of GeoVax products, raw materials, and other test articles.
• Manages reference standard system and system for assignment of lot numbers to prepared reagents.
• Corrective and Preventative Action (CAPA) investigations and follow-up activities.
• Document control of SOP’s, Work Instructions Forms, and other controlled documents
• Developed SOP’s
Tenisia Ransom, MBA
2111 Plantation Ct.
Lawrenceville, GA 30044
678-***-**** (cell)
*************@***.***
www.linkedin.com/in/tenisiaransom
• Write and/or review CoAs (vaccine product), batch records, validation records, and other documents used for
official reporting of test data on equipment and materials.
• Project Management
• Manages laboratory operation workflow, oversees laboratory investigations and provides technical assistance to all
team members. Ensures that all safety, cGMP and SOP policies and/or procedures are followed
• Designed and implemented Lean Project: Kanbans for the entire lab.
• Perform IQ/OQ protocols on entire equipment inventory.
• Validation of GMP equipment
• Document Controls
• Ensures cGMP compliance in all aspects of the laboratory functions.
• Trained employees on the new Kanban systems implemented as well as twenty five new SOP's I developed.
• Developed the Disaster Readiness Plan, Chemical Hygiene Plan, and the Biosafety Hazards.
• Trained employees on Biosafety Hazards, Chemical Hygiene Plan, and the Disaster Readiness Plan.
DENDREON, Union City, GA May 2011 – Dec 2011
Cancer Research- Provenge
Manufacturing Associate II/Trainer
Provided support to all associates. Promoted to trainer within two months of employment.
• Aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room
environment (Class 10,000/ISO7, and Class 100,000/ISO8).
* Instrumentation Validation
* Trained new employees on aseptic techniques and clean-room gowning.
• Weighed, measured and checked raw materials to ensure batches manufactured contain proper ingredients and
quantities.
• Helped in validating processes and equipment that are directly related to filtration, cleaning and sterilization.
• Maintained records to comply with regulatory requirements and acts as subject matter expert for revisions or
improvements to manufacturing documents.
• Worked with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of
clinical and commercial products using Standard Operating Procedures.
• Oversaw gowning and basic clean room supply stocking.
• Mentored new Manufacturing Associates.
• Represented department in cross-functional teams, projects and GXP-related problem resolution
QUEST DIAGNOSTICS, Tucker, GA Nov 1995 – May 2011
Employer Solution- Drug Testing
FORENSIC SCIENTIST I
Coordinated and confirmed method and instrumentation validation studies. Oversaw all confirmation method, LOD, LOQ, carryover,
interference and linearity evaluations, production activities using the TECAN-Genesis and TEMO. Direct production using the GCMS,
HPLC, AU5400, AU5200, and GC. Wrote and corrected SOP’s.
• Orchestrated training manual for Oral Fluid Screening and Hair Screening. This manual became guide to
understanding the process for all new employees.
• Trained employees on how to use the TECAN-Genesis equipment as well as the TEMO.
Senior Lab Assistant
• Lean/Six Sigma/5S Projects
• Directed work flow and training of lab assistants where it was needed.
• Initiated Ergonomics Team that was later implemented for all of Quest employees to follow nationwide.
Resulted in less workforce injuries and fatigues.
Tenisia Ransom, MBA
2111 Plantation Ct.
Lawrenceville, GA 30044
678-***-**** (cell)
*************@***.***
www.linkedin.com/in/tenisiaransom
• Safety Officer in charge of departmental inspections, workforce injury write-ups and follow-ups, OSHA
mandated inspections, QA and QC.
EDUCATION
M.B.A, Executive, Colorado Technical University
B.S., Chemistry, Savannah State University
A.A., Education, Chabot College, Hayward, CA
CERTIFICATIONS
Change Management Business Management Lab Assistant
CAPABILITIES/VALIDATIONS
TECAN-Genesis, Olympus AU5200 TEMO
GCMS ORACLE HPLC
AU5400 STARSED
AUTOCOMPACTS
Plate Readers BAYER ATLAS Facilitator
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