Quality Control Manufacturing

Lan Bui

** ******** ****, *********, ** *****

508-***-**** ( ********@*****.***

Qualifications Profile

Organized, responsible, and hard-working professional with years of

experience in pharmaceutical manufacturing seeking to make contributions as

Manufacturing Technician.

> Well versed in biomanufacturing fundamentals; recent training includes

fermentation operations, media preparation / seed inoculums, aseptic

processing in biosafety cabinets, centrifugation, buffer preparation,

tangential flow concentration and diafiltration, column chromatography

and purification processes, column packing and qualification,

filtration and integrity testing, operating analytical

instrumentation, and performing lab calculations.

> Expertise in operating and maintaining broad range of pharmaceutical

manufacturing equipment, material handling equipment, and

environmental monitoring devices.

> In-depth knowledge of cGMPs, SOPs, OSHA requirements, and safety

procedures; proven ability to remain compliant with exacting industry

and Federal regulatory controls.

> Strong collaborative skills, working effectively in dynamic team

environments with shifting priorities; recognized for willingness to

contribute outside of normally scheduled hours to meet

> Detail-focused and highly accurate in performing mathematical

calculations and maintaining logs, records and other documentation.

> Active participant in 5S and LEAN manufacturing activities that

improve work processes and

Professional Experience

AstraZeneca, Westborough, MA

Component Preparation Operator, 2/2001 - 5/2011

Played key role in preparation of components, aseptic equipment and aseptic

area necessary for on-time production start up and product manufacturing

for global pharmaceutical and biologics leader. Operated and kept

preparation area equipment cleaned and maintained; performed detailed

inspections of machine parts to identify necessary repairs or replacements.

Utilized variety of precision instruments to perform sampling for

environmental applications and monitor classified areas up to Class 100.

. Expertly performed complete area sanitization, maintaining aseptic

certification status for operations inside Class 100 and Class 10,000

Aseptic Core.

. Performed 5S activities, drawing upon proven methodology to keep

operating areas organized for safety, efficiency, and effectiveness.

. Maintained constant awareness of area environmental conditions through

skilled use of sterilizing chart recorders, temperature and relative

humidity recorders, and particulate monitor records; reacted quickly

and appropriately to correct abnormal conditions.

. Complied with stringent SOPs and guidelines for handling potentially

hazardous materials including solvents, acids, bases, and chemical

disinfectants and cleaning agents.

. Calculated chemical quantities, load sizes and other batch

requirements, and ensured accuracy of entries into batch records and

GMP documentation.

. Demonstrated proficiency utilizing wide range of preparation area

equipment including formulation tanks and vessels, barrier and

isolation systems, autoclaves, Huber processing equipment, valves,

glassware, pH meters and probes, filter integrity test equipment,

printers, dry heat sterilizers and weigh scales

. Safely operated material handling equipment including pallet jacks,

ergo lifts, drum lifts and small forklifts.

AstraZeneca, Westborough, MA

Aseptic Manufacturing Operator / Inspector, 4/1994 - 1/2001

Performed cleaning, sterilization and onsite inspection within aseptic,

steel core production area.

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Additional experience in pharmaceutical production and quality control as

Packaging Operator at AstraZeneca

Educational Background

Fundamentals of Biomanufacturing - Spring 2012

WPI Corporate and Professional Education - Worcester, MA

Phlebotomy Certificate

The Field Stone School - Worcester, MA

Glassboro College

General Education Development - Glassboro, NJ

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