Jo'Nie Jefferson
Operations Specialist II
Jonesboro,GA
Summary
Forward-thinking Operations Specialist with over 15 years of expertise in Pharmaceutical Manufacturing. Solid experience with microbial and analytical chemistry test and equipment. Strict adherence to GMP, GLP, FDA CFR 21 and OHSA standards. Management of assay and SOP development to optimize project goals, output, resolve complex problems and deliver innovative improvement strategies. Proficient in both quantitative and qualitative analysis and data presentation. Outstanding use and interpretation of ChemStation, LIMS, TrackWise, DMAIC & root cause analysis, HPLC, GC, MS, AA, and IC.
Overview
15
15
years of professional experience
6
6
years of post-secondary education
Work History
Operations Specialist II
Takeda Pharmaceuticals
Socail Circle, GA
09.2019 - Current
- Drive manufacturing deliverables to ensure quality commerical operations.
- Lead and implement Change Controls.
- Identify and implement process improvement by leading root cause analysis with use if DMAIC tools
- Manage deviations in TrackWise system to ensure timely closure.
- Enforced regulatory and company compliance to improve workplace and employee safety and audit readiness.
- Compiled training materials for new employees and track skill development.
- Author technical reports to document deviations and non conformances.
- Expand knowledge of manufacturing principles and support systems and programs.
- Use of 6 sigma and LEAN methodologies.
Quality Assurance Analyst II
Baxalta / Shire
Social Circle, GA
03.2016 - 09.2019
- Defined and implemented quality initiatives to reduce risk.
- Created and revised procedures, data forms and job aids to reduce errors.
- Developed and implemented quality control processes to meet product standards under FDA CFR 21.
- Conducted chemical and microbial assays on raw materials, intermediates and finished product.
- Identified microorganisms to species level recovered from product and environmental sampling.
- Performed laboratory and documentation audits.
- Performed tests and inspections to conform to established standards.
- Drafted technical documents such as deviation reports, testing protocols and trend analyses.
- Monitored testing procedures and verified performance of tests according to established item specifications and protocol.
Laboratory Supervisor
Georgia Pacific
Monticello, GA
08.2015 - 01.2016
- Weekly Impinger calibration preformed on DMC using wet chemistry procedures.
- Responsible for instrument calibration, maintenance and troubleshooting of DMC, serving as primary operator of impinger performance for assay integrity.
- Managed lab inventory.
- Directed quality assurance standards to maximize results.
- Managed employee schedules according to individual needs and skills, as well as coverage requirements.
- Maintained 4 databases (including excel and LIMS) of lab results.
- Responsible for timely release of product.
- Report OOS results to TECO and QYM (quality yield manager)
Manufacturing Process Associate
Amgen Inc
Thousand Oaks, CA
04.2013 - 07.2015
- Responsible for strict adherence to current Good Manufacturing Practices (cGMPs).
- Accurately completed process associated documentation, make calculations and perform physical tasks associated with large scale pharmaceutical manufacturing.
- Responsible for manual and automated equipment cleaning and sterilization.
- Solution/Drug product preparation, testing and transfer.
- Assembly / disassembly of valves, filtration assemblies, and associated chromatography equipment.
- Sample collection, processing and storage.
- Aseptic gowning in ISO 5/6 environment.
- Completion of batch records, forms, equipment / facility logs and labels.
- Support other manufacturing operations (e.g., Inspection and Packaging) as needed.
- Identified and resolved process issues to drive optimal workflow and business growth.
Education
Associate of Science - Chemical Technology
Los Angeles Trade Technical College
Los Angeles, CA 09.2008 - 05.2009
Bachelor of Science - Biological Science
Grambling State University
Grambling, LA 08.2003 - 05.2007
Skills
Lean Six Sigma operations
Root Cause Analysis
Analytical and Critical Thinking
Self-Motivated
Dependable and Responsible
Written Communication
Timeline
Operations Specialist II
Takeda Pharmaceuticals
09.2019 - Current
Quality Assurance Analyst II
Baxalta / Shire
03.2016 - 09.2019
Laboratory Supervisor
Georgia Pacific
08.2015 - 01.2016
Manufacturing Process Associate
Amgen Inc
04.2013 - 07.2015
Associate of Science - Chemical Technology
Los Angeles Trade Technical College
09.2008 - 05.2009
Bachelor of Science - Biological Science
Grambling State University
08.2003 - 05.2007