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Quality Assurance Control

Location:
Washington
Posted:
January 23, 2014

Contact this candidate

Resume:

JAMONTE WILLIAMSON

PO Box ***

Zebulon, North Carolina 27597

919-***-****

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

? Page 2 ?

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

? Page 3 ?

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

919-***-**** H 252-***-**** W

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



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