Ti’Hesha Everett

Union City, GA *****

ad1hhl@r.postjobfree.com

404-***-**** cell

OBJECTIVE Driven manager seeking a position in a company to contribute managerial and leadership skills. In the last 12 years I’ve built some great teams that have led me to increase my departments’ productivity rate by 35%. I am passionate about meeting target goals, and I hope to contribute my skill set to the future success of your company.

SUMMARY A highly proficient and forward-thinking Analytical and Quality Lab Professional with over 17 years of experience in Quality Assurance (ISO, GMP, ICH), Laboratory Management (ISO 9001 for Quality Management Systems and ISO 10006 for Quality Management in projects), cGMP, cGLP, OSHA, ISO), Employee training, and Laboratory Analysis (USP, EU, ASTM, EPA, FDA, CLIA, ICH). Excels at addressing issues, including quality, delays and wasted resources to ensure timely and efficient completion of all projects. A proven track record of applying diverse skill set and meticulous approach within the manufacturing and pharmaceutical industries and quality government agencies. A savvy resourceful producer and self-starter who can cultivate collaboration and well-managed deliverables to ensure long-term success.

Seeking leadership position that supports the parent organization by providing cost savings and product quality improvement measures through process analysis, a safety-first mindset, quality systems implementation, and team skills development. First Aid, CPR, 24 HAZWOPER and Six Sigma certified.

EDUCATION BACHELOR OF SCIENCE IN CHEMISTRY, DEC 2005

COLUMBUS STATE UNIVERSITY, COLUMBUS, GEORGIA

GPA 3.3

EXPERIENCE

Redbock NES Fircroft

Analytical Consultant (07/2022 – 07/2023)

Pioneered a framework for establishing benchmarks for Operational Excellence in a GMP lab setting by working closely with lab area leads to evaluate current processes in detail.

Developed key initiatives and changes towards compliance and efficiency of processes, making them more flexible and efficient by maintaining compliance to 21 CFR Part 820 for cGMP and quality systems regulation and document control, quality audits, ensuring sufficient personnel, manufacturing design and process controls, Nonconforming products, CAPA, labeling, etc.

Monitored GMP systems and executed continuous improvements for the Irvine site.

Established sites environmental health and safety teams, including the Emergency Response Team (ERT) and the site Safety, Ergonomic and Environmental (S.E.E.) Committee using guidance from 29 CFR Part 19 Occupational Safety and Health Standards for Emergency planning and exit routes, Environmental controls and Hazardous materials, PPE, Medical services and first aid.

Recovered thousands of dollars in time-cost revenue by Optimizing company processes, creating procedures to reduce department bottlenecks.

Pinova Inc.

Analytical Chemist/Quality Control Lab Manager (01/2020-08/2022)

Hired to lead change in the Analytical/QC department improve operational efficiency and compliance, and to provide the scientific guidance needed to support the manufacturing of specialty rosin and polyterpine resin products.

Manage 15 direct reports and a wide variety of analytical chemistry tests required to characterize product, intermediates and raw materials as well as manage the technicians who perform the analyses in the laboratory.

Train laboratory staff on new instrumentation and modified and new analytical test method SOP’s.

Revamped job duties (organizational management) creating transparency and SMART goals.

Successfully increased department productivity by implementing Six Sigma, Kanban, Lean Manufacturing, Kaizen and 5S principles in the lab as well as supporting other plant departments and their similar initiatives. implementation and follow-up), and continuous improvement (through developing and implementing a training regimen for Technicians and Chemists).

Mentor and develop staff members, in support of strategic business needs, ensure training levels are maintained for all members, sets objectives for, and manage the activities of team members and evaluates performance.

Slashed analytical consumable costs 20% by negotiating pricing and fees and implementing a Vendor Managed Inventory (VMI) system with a local vendor.

Manage the operation of the QC Lab. Coordinate and schedule all activities associated with the laboratory, track, and report metrics as they apply to the specific processes, and act when unfavorable trends or other issues arise.

Develop and implement new Analytical protocols to define operation of the instrument, preventive maintenance and calibration procedures for all lab instruments and testing protocols.

Coordinates all activities relevant to FDA and ISO 9001 for Quality Management Systems and ISO 10006 for Quality Management in projects (first and third party) regulatory audits as well as customer audits.

Conducts internal compliance audits as required and maintains facility quality records and procedures.

Co-responsibility for Quality Team operations including department, process, and customer audits (internal and external), system improvements (through corrective action identification, implementation, and follow-up), and continuous improvement (through developing and implementing a training regimen for technicians and chemists).

Manage (conducting and writing) investigations for quality events (QE’s) including, Change Controls, Non-Conformances, Deviations, CAPA and OOS/OOT investigations for raw materials and intermediates, and to support batch release by using problem solving tools (Root Cause Analysis, 5 whys, 5M’s)

Responsible for the establishment and implementation of all laboratory service policies, standards, and procedures.

Implemented online testing using Near-IR/algorithms which produce results in <3 mins

Manage the installation and qualification of new instrumentation / equipment in the laboratory to include working with instrument vendors to develop and execute IQ/OQ/PQ qualification protocols to qualify a new lab instrument prior to putting the instrument into service.

Perform instrument troubleshooting and repair, validation, maintenance, and test method development and deployment for various analytical instrumentation

Analyze, interpret, document, and effectively communicate results of lab work for timely decision making on projects and technical support initiatives.

Implement all aspects of lab work in a safe work environment and provide input on improving or upgrading capabilities within the laboratory to enhance efficiency/productivity.

Curia (formerly) Albany Molecular Research, Inc.

Lab Manager/Senior Research Scientist (7/2017-11/2019)

Implements work plans; conducts performance reviews and appraises performance for 20 direct reports (managers, supervisors, and analysts); identifies and recommends career development opportunities with employees.

Exercises considerable latitude in determining technical objectives of assignment while fostering a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork.

Maintain effective communications with my team and other departments by communicating department issues and providing status updates to the management team.

Reviewed Method Validations, Method Transfers, Process Performance Qualifications, and analyst qualification to comply with FDA guidance.

Communicate and enforce QC requirements to team personnel and ensure they are completed as per GLP, GMP and FDA, and ISO standards in a CRO/CMO.

Develop, implement, and ensure adherence to current and new revisions of laboratory Analytical testing protocols. Also assisted analysts with review of Analytical test data and approved final reports.

Facilitate initial and intermittent training of QC analysts.

Participate in initiatives to improve employee engagement to positively impact operational results and employee retention.

Spear-headed initiatives to obtain a LIMS system for the site.

Manage (conducting and writing) investigations for quality events (QE’s) including, Change Controls, Non-Conformances, Deviations, CAPA and OOS/OOT investigations for raw materials, intermediates, API’s and to support batch release by using problem solving tools (Root Cause Analysis, 5 whys, 5M’s)

Experienced testing of various drug products, oral and subcutaneous, Active Pharmaceutical Ingredients (API’s), stability testing, controlled substances, and raw materials.

Proficient in analysis and training with the following equipment: HPLC, GC, GPC, UV-Vis, IR, USP and EP Monograph Testing, Particle Size Analyzer, KF Titration (Metrohm), XRPD, XRF, and numerous wet chemistry analyses.

Allnex

Analytical Chemist/Lab Manager (3/2015 – 7/2017)

Solely managed Analytical Lab including troubleshooting and calibration of equipment.

Coordinator and provider of all analytical testing support in a cross functional team environment, at the North America Alpharetta site.

Independently manage analytical support for all Coatings (XLR R&D, TS&D, LRA, Radcure and Powder TS&D projects).

Good time management and prioritization of project work

Method development and validation for HPLC, GC and GPC

Write and update SOP’s

Maintained detailed and accurate reports for projects, experiments, and analyses

Perform analyses using a variety of wet chemistry methods and general laboratory instrumentation to include FTIR, pH meters, titrators, KF titrations, analytical balances, ovens, etc.

On the Safety team. Assists as a 1st responder by being CPR and First Aid certified. Also, on the Hazmat team to contain and clean up spills

Completed Six Sigma Green Belt training

Renmatix

Senior Analytical Chemist/Lab Lead (1/2011 – 3/2015)

Lead liquid hydrolysis team (4 direct reports)

Attend and present at company meetings

Maintained detailed and accurate reports for all weekly analysis and turnaround time

Trained and supervised new team members on all analytical processes

Assist in experiments to trouble shoot issues with improving analytical data

Method development and validation on HPLC and GC systems

Developed Company Training protocol

Analyze cellulosic sugars that are extracted from biomass on HPLC and GC systems using Agilent Technology and Perkin Elmer instruments for batch processing of data analysis using Chemstation and Chameleon software

Full working knowledge of the following instrumentation: Analysis of moisture content using a moisture analyzer, UV-VIS, FTIR, titrator, pH meter, drying oven, capillary suction timer, HPLC, GC-MS, Dionex, Near IR, autoclave, oil bath, pipettes (auto and manual),

release and disposition of product under minimal supervision.

Centers for Disease Control and Prevention (CDC) (Contract)

Research Scientist (6/2006 – 3/2008)

Skills/Expertise: Molecular Biology, Immunology, and Virology:

Real-Time and Conventional RT-PCR Assay Method Development

Experienced in determination by Bioassay

Gel electrophoresis

RNA & DNA extraction and purification and DNA sequencing and analysis

Supervised maintenance of lab equipment and supplies

Assist State Health Departments with assay validation and maintenance of current laboratory protocols

Responsible for laboratory equipment, chemical and reagent purchases.

Proficient using various instrumentation such as, Triturus ELISA robot, Vidas, Lightcyclers 1 and 2, MagNA Pure, Nuclisens, and Kingfisher automated extractors, Sequencer, and Nanodrop spectrophotometer

Software: Microsoft Word, Excel, Outlook, Access, Power Point, Triturus, Vidas, MagNA Pure, Lightcycler 3.0 and 4.05, Sequencher 3.7 and 4.0, BioEdit.

Experience working in BSL-1, 2, and 3 labs.

Evaluate advanced PCR techniques for the detection of Norovirus in clinical samples. Write and update molecular techniques protocols (SOP’s) for the detection of enteric viruses in a regulated GLP/GMP environment and follow all CLIA guidelines.

Assist state laboratories in real-time RT-PCR, validation, and troubleshooting.

Train co-workers, visiting scientists, and summer interns in incoming specimen receipt and tracking, real-time RT-PCR, PCR, RNA and DNA extraction, purification, sequencing, genome amplification, data analysis, record keeping and gel electrophoresis

Created and maintained intra-departmental databases for tracking all incoming specimens and lab results. Also familiar with the LIMS system.

Perform serological assay on various clinical specimens including elution of DBS for IgG and IgM testing

Perform DNA extraction on stool, emesis, whole blood, saliva, urine, vaginal fluid, dried blood spots, and semen using both automated and manual methods and worked with serum, plasma, and peripheral blood mononuclear cells (PBMC’s). Also familiar with harvesting cells from CPT tubes and performing cell counts.

Licenses and

Certifications

Lean2020

Six Sigma White and Yellow Belt and Lean Manufacturing

Issued 2021

ASQ

Certified SPC Basics and Advanced

Issued 2020

PROFFESIONAL

AFFILIATIONS American Society for Quality (ASQ)

American Chemical Society (ACS)

Additional Skills

●HAZWOPER 40 Hour Certification 29 CFR 1910.120 and

8 Hour Refresher Certification

HAZMAT 40 Hour Certification

●HAZWOPER Incident Commander Training

●HAZWOPER First Responder Awareness Training

●Hazardous Waste Generator Training

●Hazardous Waste Operations and Emergency Response Training

●First Aid CPR/AED Certified

Publications:

Anandi N. Sheth, G. Ewald, K. Fleming, K. Kornylo, M. Menon, S. Harris, N. Seerpi, T. Allen, J. Vinjé, J. Sobel.

Persistent Outbreak of Gastroenteritis Spanning Multiple Cruises of a Domestic Riverboat—Ohio and Mississippi Rivers, 2006. Epidemic Intelligence Service Conference (Centers for Disease Control) 2006

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