Quality Assurance Supply Chain

Oulakone Souvanthong

**** ***** ****** #* ( EL CAJON, CALIFORNIA 92021 (

abhtuw@r.postjobfree.com 858-***-****

Biotechnology Operations Specialist

Analytical, meticulous professional with extensive experience in

biotechnology environments; excel at receiving, handling, assembling,

packaging, and maintaining complex surgical kits.

Areas of Expertise

. Comprehensive understanding of biotechnology product manufacturing

operations, business processes, and regulatory environments.

. Collaborate cross-functionally in support of surgical kit part inventory,

kit assembly, and distribution, as well as used kit receipt, quarantine

and cleaning, and re-inventory.

. Adept at the product inventory lifecycle, prioritizing distributions and

delivery in alignment with production schedule.

. Broad-based knowledge of biotechnology manufacturing environment safety /

quality standards, processes, policies, and guidelines.

. UTILIZE AND MAINTAIN COMPLEX LABORATORY EQUIPMENT AND INSTRUMENTS AND

PROVIDE TRAINING AND INSTRUCTION ON PROCEDURES TO NEW STAFF.

. Outstanding communication, collaboration, and relationship development

acumen.

Professional Experience

VertiFlex, inc. - San Clemente, California

Operations Specialist, 2007 to 2010

Received and decontaminated incoming field surgery kits for startup spinal

surgery product developer, performing material handling, kit cleaning, part

inventory, kit assembly, and distribution. Tracked inventory and utilized

build of materials documentation in NetSuite ERP system.

. Drove a 35% reduction in shipping costs through transition to free

shipping materials; managed shipping processes with UPS and FedEx.

. Cleaned surgical kits using Alconox cleaning solution, sonnacator, and

autoclave.

. Inventoried parts released from inspection and performed full inventory

counts every 3 months.

. Routinely provided training to new employees in groups of 3+, across

processes, policies, and safety standards.

. Integral in the planning and setup of a new "clean non-sterile"

facility.

. Earned the Worker of the Year Award for consistently superior

performance and contribution; achieved and sustained a 99.99% rate of

accuracy.

Nexa Orthopedics, Inc. - San Diego, California

Materials Handler, 2005 to 2007

Managed diverse material receiving, processing, and logistics within

surgical device manufacturer, as well as held full responsibility for

material issuance throughout the organization. Utilized QAD ERP to record

and process returned surgical kits prior to quarantine; performed the

"clean non-sterile" process. Led biweekly cycle counts for finished

products.

. Played instrumental role in establishment of the clean room, including

design and layout; following implementation, managed clean room log

book and "clean non-sterile" maintenance.

CardioDynamics, The ICG Company - San Diego, California

Materials Handler III, 2003 to 2005

Manufacturing, QA & Logistics Coordinator, 1999 to 2003

Advanced from QA and supply chain coordination role to position accountable

for all aspects of material receipt, recording, inventory, tracking, and

distribution within cardiac biotechnology provider. Leveraged Manage 2000

ERP to conduct cycle counts and perform manufacturing material issuance;

prioritized and developed pick lists for manufacturing orders.

. Performed inventory receipt, processing, tracking, and control for 1K-

2K items per month.

. Utilized Fourth Shift ERP and FIFO methodologies to administer and

track items from quarantine through pre-inspection, and then from

inventory to issuance.

. Performed QA inspection of parts and assemblies against engineering

schematics and drawings, establishing appropriate grounding for

handling of electrostatic sensitive devices (ESD); developed non-

conforming materials reporting for the Material Review Board (MRB).

. Provided assistance to shipping function, assembling, packing, and

shipping orders.

Technical Proficiencies

Technology: Windows, Microsoft Office Suite (Word, Excel, Access,

PowerPoint, Outlook), Netsuite ERP, Fourth Shift ERP, QAD ERP, Manage 2000

ERP, FedEx & UPS Manager

Equipment: Microscopes, Calipers, Autoclave, Bar Tender Labeler, ULine

Impulse Sealer, Sonicator, GD&T, ESD Handling, Forklift

Methodologies: GMP / cGMP, Quality Assurance / Control (QA / QC) &

Inspection, NMR Non-Conformance Reporting, Sterilization, Decontamination,

FIFO Stocking, Quarantine

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