JAMONTE WILLIAMSON
PO Box ***
Zebulon, North Carolina 27597
accahk@r.postjobfree.com
JAMONTE WILLIAMSON
accahk@r.postjobfree.com
PO Box 785 919-***-****
Zebulon, North Carolina
27597
MANUFACTURING OPERATIONS SUPERVISOR
~ pharmaceutical industry focus ~
PROFESSIONAL PROFILE
Consummate professional with expertise in quality assurance,
pharmaceutical manufacturing and operations. Experience serving with
industry leaders in pharmaceutical manufacturing industry. Accountable
for adherence to the cGMPs and operation of manufacturing equipment.
Eighteen years of experience in the pharmaceutical manufacturing
industry, with eight years in a leadership role.
Fully qualified to perform routine pharmaceutical product processing
activities within a pharmaceutical cleanroom environment according to
Good Manufacturing Practice. Able to ensure all activities follow
standard operating procedures, assist in the compilation of all batch
manufacturing records and other reports generated within the relevant
section, document incidents fully, correctly and in a timely manner, and
maintain relevant equipment logs.
Manages manufacturing activities, ensuring that all regulatory
requirements are met. Works on moderately complex problems requiring
evaluations of multiple factors before resolution can be reached.
Exercises judgment within defined practices and policies. SAP Champion
with extensive background in AMAPS and SAP operations; successfully led
launches of several new product lines.
Effectively interacts with senior management; able to interface with
contract sites to ensure production flows smoothly and that all company
requirements are met. Identifies creative solutions to diversified
challenges within a strictly regulated environment. Management
experience in pharmaceutical product processing activities, cleanroom
environments, resource planning, budgeting and performance forecasting.
Maintains professional discipline while working, informing management of
any problems related to the manufacturing activities. Maintains
cleanliness in the manufacturing area. Able to conduct/write
investigations and deviations, and perform training.
Experience in mixing and blending, compression, capsulation and coating;
strong experience in FDA, cGMP, and OSHA regulations. Extensive
background in AMAPS and SAP operations, currently a SAP champion. Served
as several development teams that successfully launched several new
product lines.
Relentlessly pursues superior customer service excellence. Accomplished
in managing cross-functional, pharmaceutical production, manufacturing,
and quality control teams. Able to serve as Manufacturing Supervisor in
a pharmaceutical production environment.
CORE COMPETENCIES & TRAINING
AMAPS / SAP Expert Quality Assurance Manufacturing Process
OSHA / cGMP Management Controls cGMP / SOPs
Compliance Management Protocol Compliance Compliance Consulting
Certified Mentor and Multi-Task Project Work Test Metrics / Reporting /
Trainer Process Leader Team Trainer / Mentorship Management Reporting
Equipment / Supervision Creative Problem Solving
Specification/Calibration Bio Works 101 Personnel & Team
(Pharmaceuticals Class) Development Strategies
Lean Six Sigma Testing on Control &
Equipment
JAMONTE WILLIAMSON
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PROFESSIONAL EXPERIENCE / CAREER ADVANCEMENT
MERCK & CO., Raleigh, NC
VBF Vaccine Specialist (2012-2013)
Key Responsibilities & Proof of Performance:
. Developed and maintained specialized expertise in vaccine therapeutic
areas, products and markets while demonstrating knowledge of VBF
vaccines, competitive products and promotional strategies and objectives
to educate clients and win repeat business and sales. Successfully used
high-level selling and marketing skills, including account-based selling
and strategic thinking that drove results and earned key accounts.
. Frequently provided service to a variety of key accounts through a
customized blending of science & service based upon each accounts
individual needs. Demonstrated the ability to effectively follow and
use the vaccines sales process in a way that engaged customers and
ultimately led to vaccines purchases. Collaborated with Vaccines
partners, including PAMs, to help pull through MERCK & CO. Vaccine
doses. Provided all documentation and clerical functions necessary to
allow proper accountability and traceability of product.
. Maintained, inventoried, and transported all required equipment,
materials, supplies and products. Ensured shipment criteria and timely
availability and delivery. Performed general maintenance and assisted
in troubleshooting of sensitive equipment. Ensured sanitary conditions
in all work areas. Executed facility decontamination according to
approved company procedures. Completed sampling and in-process testing
to support the manufacturing and validation process for current process
as well as developmental work for new products and processes.
. Successfully identified and addressed compliance, environmental, safety,
and process deviations as appropriate while notifying appropriate
personnel. Maintained, cleaned and prepared equipment used in vaccine
production. Scheduled and performed environmental monitoring during
processing and recorded results in the computerized database system.
BECTON DICKERSON, Durham, NC
Production Team Leader / Manufacturing Technician III (2011-2012)
Key Responsibilities & Proof of Performance:
. Successfully and continually monitored operations for product quality
and equipment performance in a medical production setting. Made key
adjustments to equipment as needed to maintain process quality and
productivity while minimizing redundancies in the production line.
Implemented and executed with product and equipment changeovers.
Responsible for QSR/GMPs, high speed efficiency, process improvement,
lean manufacturing, and team development.
. Employed management motivation using six sigma principles to achieve and
exceed production objectives, quality standards, process yields, and
machine efficiencies.
. Guided and mentored a team of 10 line technicians and setter/operators
with equipment repair or troubleshooting. Successfully kept machinery,
work area and floors neat and orderly in order to comply with GMP
requirements. Performed quality inspections, process tests and record
data accurately as required.
. Communicated with utilities and department scheduling group to maintain
minimal material inventory levels. Worked as high-level team member to
develop optimal task methods.
. Directs all component manufacturing Bulking/Compounding operations both
large and small scale in Immunodiagnostics MFG and responsible for
completion of all Manufacturing Directions for Bulking and Filling
. Trained in all media prep formulation bulking, cGMP areas, SOP and
Manufacturing Documentation and Microbial Upstream Manufacturing
processes; safely operated multiple types of Centrifuges (two and three
phase operations) and frequently worked with pressurized vessels
UNITED THERAPEUTICS, Raleigh, NC
Senior Research & Pharmaceutical Technician / Supervisor (2008-2011)
Key Responsibilities & Proof of Performance:
. Served as a certified technician and supervisor of dispensing,
granulation, compression, blending, coating (color/functional), vision
inspection, laser drilling, and printing. Responsible for ordering,
stocking, and supplying the manufacturing suite with necessary cleaning
products. Led research and development team along with manufacturing
department as the acting supervisor and process lead for a team of 15.
Assisted in the start up of the manufacturing suite from ideation to
implementation as one of two lead technicians.
. Member, trainer, and organizer of safety team, manufacturing processes,
all SOP's written and certified in the manufacturing process. Served as
the lead packaging technician, warehouse technician with forklift
certification and responsible for all scheduling.
. Liaison with Vice Presidents and Development Scientists on all new
developments pertaining to current product project.
JAMONTE WILLIAMSON
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PROFESSIONAL EXPERIENCE / CAREER ADVANCEMENT
GLAXOSMITHKLINE, Raleigh, NC
Manufacturing Operator III / Team Leader (1995 - 2008)
. Served as Manufacturing Operator directing the dispensing, compression,
aqueous granulation, solvent granulation, coating, enteric coating, and
blending of GSK proprietary products. Assisted with the drafting and
revision of department procedures and practices. Successfully used
expertise in the production of sterile production batches of GMP quality
pharmaceuticals and performed oversight on quality assurance.
. Managed quality control laboratory operations, projects, teams, and
workflow, assisting senior leadership with quality metrics, employee
training, equipment management, and reporting. Met all compliance
parameters for cGMP, FDA, and OSHA processes, protocols, and guidelines.
Adhered to all GSK corporate policies and procedures for the manufacture
of their products.
. Served as a certified trainer and mentor of new employees, assisting
them through the orientation process, and familiarization with key
equipment, and SOPs. Operated as back up process leader.
. Provided comprehensive support to all manufacturing operations and the
timely execution of tasks. Coordinated inventory controls, restocking
and reordering of materials and supplies. Ensured operations are taking
place in a pharmaceutical standard clean environment, that completed
sterile pharmaceutical processing, including formulation, sterile fill,
and lyophilyzatiion activities. Performed routine and advanced duties
required to make quality bulk and filled drug products.
RECENT EVALUATOR COMMENTS
"Jamonte was an invaluable asset to multiple DataStream projects. He
was solely responsible for the generation of complex equipment and
automation testing protocols that were created with information that
was incomplete and not readily available."
"Jamonte was very successful at the project under difficult
circumstances; he consistently delivers high quality work and is
sensitive to the needs of his client. He has built a positive
reputation for himself at the site so his participation is welcome on
any project."
"Jamonte exhibited continued success this year, particularly in his
client projects. He was single handedly responsible for turning around
some of our work in GSK."
PROFESSIONAL REFERENCES
Ami Wilkerson Cliff Wilder Anthony Lindsey Alisha Cordell
Solid Dose Coordinating Pharmaceutical Technology Project
Supervisor Supervisor Supervisor Coordinator
United Therapeutics CSX Biomerieux Merge Healthcare
919-***-**** H 919-***-**** H 919-***-**** C
Additional Information Available Upon Request
JAMONTE WILLIAMSON
accahk@r.postjobfree.com
PO Box 785 919-***-****
Zebulon, North Carolina
27597
To Whom It May Concern:
Thank you for accepting my credentials for the current Pharmaceutical
Manufacturing Supervisor opportunity with your company. I am seeking a
position with a growth-oriented, quality-driven company where experience in
pharmaceutical manufacturing will be of value.
I have experience in mixing and blending, compression, capsulation and
coating; strong experience in FDA, cGMP, and OSHA regulations. I have an
extensive background in AMAPS and SAP operations, currently a SAP champion.
I served as several development teams that successfully launched several
new product lines. I am focused on a position directing manufacturing
quality control efforts where I would be responsible for reviewing key
processes for operations and quality control, while building innovative
solutions to improve operations and team productivity.
I am accomplished in managing cross-functional, results-oriented validation
and quality assurance teams. My career foundation demonstrated operational
excellence in high-pressure, deadline-critical situations, and serving as
supply leader for clinical research and product manufacturing operations.
My training and project successes include conducting tests, writing
reports, and making recommendations on the adoption of new processes,
materials, components, and assemblies to ensure maximized and quality
controlled manufacturing environments. Focused on compliance with industry
regulatory and cGMP standards; some of my skills areas include:
Process Improvement Leading and Mediating
Testing & Incident Management Cross-Functional Groups
Reporting & Data Organization Design Quality Control Engineering Project
Management
Validation Engineering / Quality Manufacturing Process Controls
Control Innovative Problem Solving
cGMPs / SOPs Compliance Consulting Team Training
Equipment Specifications Resource Allocations
As a highly-motivated, results-oriented, and quality-focused individual, I
enjoy serving in a dynamic team environment, working with clients to ensure
the highest standards of cGMP, validation engineering, and quality controls
processes. I am known as a leader who will make informed decisions and
work cohesively with cross-functional teams to meet client deadlines and
provide the highest standards of quality assurance and pharmaceutical
manufacturing.
I would like to explore opportunities in your organization where I can
apply these skills and experiences with equal dedication in order to
contribute to your company's ongoing success.
Thank you for your time and consideration. I look forward to speaking with
you soon.
Sincerely,
Jamonte Williamson
Enclosure