Quality Assurance Customer Service
Resume:
LESLEY MCCANDLESS
Columbus, Ohio 43204
******.**********@*****.***
Professional Summary
Detail-oriented, organized "hands-on" professional with over 13+
years in Operations, Purchasing, Quality Assurance, and various
administrative support roles using SAP R/3 Software. Recognition for
taking a personal approach to provide exceptional internal and external
customer service resulting with above and beyond expected results.
Expertise in a packaging engineering and operations environment, combined
with knowledge of Current Good Manufacturing Practices, and a general
knowledge of supply chain flow, manufacturing and production.
Skills and Qualifications
SAP Business Software Training and Events for Windows XP
Purchasing Reporting Administrators Word, Excel, PowerPoint,
Manufacturing Data Inquiry Dispensing Access
Inventory Control Production Reporting ADP, RECORD, IDEA4Gen
Coordinator Production Execution WebTop, Reynolds, Citrix/PMD
Engineering Change Request Manufacturing Execution
Creation/Display Visio, PRISM, TrackWise,
SnagIT
ARIBA, eForms, QSDB, CPD-2
Education
Accounting and Business Administration with a Minor in Project Management
(pursuing)
Franklin University, Columbus, Ohio
Associate Degree in Business Administration Ohio Dominican
University, Columbus, Ohio
Professional Experience
Sixarp, LLC - Praxis Packaging, Grand Rapids, MI 2009 to 2010
Quality Assurance Supervisor
11/2009 - 02/2010
. Provided timely training to Quality Assurance Auditors and applicable
Praxis employees resulting in all employees being trained on latest
procedural updates.
. Submitted weekly Quality Activity Reports to Vice President of Quality
for weekly reporting to the owners.
. Reviewed and stored Major Equipment and Portable Equipment log books
resulting in compliancy for SOPs.
. Maintained IQ, OQ and PQ books for equipment resulting in storage in
orderly fashion for the facility.
. Time card keeper using ezLabor to ensure payroll runs for weekly pay
date.
. Arranged Corrective Action/Preventative Action reports to understand and
identify root cause analysis.
. Quizzed employees regarding company policies, practices, procedures and
work instructions to ensure training was effective.
. Ensure Current Good Manufacturing Practices, Standard Operating
Procedures and Working Instructions are followed for proper execution of
customer orders.
Administrative Assistant, Human Resources
09/2009 - 11/2009
. Created spread sheets and charts for tracking business issues resulting
in simplified tracking for managers and team members.
. Greeted visitors in a friendly, professional and courteous manner to
ensure they are welcomed according to outlined procedure.
. Answered telephones and direct callers to appropriate department.
. Performed company-wide operating inventory prior to preparing purchase
order requisition forms to make sure supplies are on hand for production
resulting in no down time.
. Performed new hire orientation to ensure new hires understand
expectations of the business.
Boehringer Ingelheim Roxane, Inc., Columbus, Ohio 1996 to 2009
COORDINATOR II, PACKAGE ENGINEERING
2005 - 2009
. Provide support for one Director, one Associate Director, three Section
Heads, and 9 Package Engineers.
. Coordinate and manage various technical projects in compliance with
specific FDA requirements for consumer consumption including working
knowledge of current Good Manufacturing Practices.
. Executed orders for MRO supplies for procurement of package engineering
line trial components while remaining within budgeted cost allowance of
$30K per month.
. Provide internal customer service and coordination to all necessary
departments pertaining to consumer consumption of pharmaceutical
projects consisting of gathering quotes/bids within a 48-hour turn
around.
. Worked with Graphics to construct new and update existing labeling
components.
. Served as critical member of Package Component Specification (PCS) team
tasked to identify discontinued specs and upgrade current PCS resulting
in simplification and storage for all departments.
. Created and maintained Master Packaging Specifications (MPS) resulting
in stream-lining MPS's reduced change over time and increased packaging
line efficiencies.
. Worked with Quality Assurance to resolve incoming material issues and
issues with existing materials.
. Reviewed and maintained Bill of Material documentation in SAP.
. Selected as the trainer by Learning Resources to train all Package
Engineering and other functional areas resulting in compliance
adherence for monthly training requirements.
. Prepared and participated in line trials for new materials and
packaging equipment.
COORDINATOR I, PACKAGE ADMINISTRATION 1999 - 2005
Reviewed Solids and MDI manufacturing process orders for accuracy.
. Directly involved with the management of Warehouse components and
Labeling materials in SAP. Executed various SAP transactions and
department payroll updates.
. Created and executed all new procedure training, appointments,
meetings, Excel spreadsheets, Word documents, and various travel
accommodations.
. Provide support for the management team consisting of one director
three Packaging Operations managers and eight unit leaders.
. Reconciled departmental Purchasing card statements, inventory and order
replenishment supplies via ARIBA purchasing software.
. Generated reports in SAP, prepare VISA expense reports for managers and
directors.
. Collaborated with team leaders, unit leaders and Quality Assurance to
establish a review guide to target high correction areas resulting in
reduced documentation errors increasing batch record release.
. Resolved inventory issues based on open bin report resulting in better
accuracy of inventory usage of components.
. Created detailed instructions for packaging personnel to recondition
production runs as required meeting the need of the business
resulting on reduced back order of specific SKU (stock keeping unit)
numbers.
. Provide back up to other functional areas to ensure that batch records
were released to Quality Assurance within the allotted 2 day turn
around to meet the release adherence.
. Performed payroll functions for 150 packaging personnel to insure that
all exceptions were updated in order to meet the payroll processing
within guideline criteria for processing.
MATERIAL HANDLER 1997 - 1999
. Opened, inspected and issued credit to pharmacies and wholesalers for
pharmaceuticals.
. Prepared clinical trial data for destruction, and generated
spreadsheets for data analysis.
. Interacted with BIPI Customer Service to resolve credit and outdated
product issues.
. Opened and inspected pharmaceutical products resulting in timely
refunds as applicable.
. Organized returned clinical trial material resorts showing quantities
of material being returned for destruction purposes to show trending
for refund purposes.
. Prepared clinical trial material returned for destruction.
. Operated forklift to store and retrieve pallets of product or
information.
PACKAGING WORKER 1996 - 1997
. Packaged pharmaceuticals for aseptic use, cleaned and prepared
equipment for packaging batches, prepared documentation for packaging
batches.
. Weighed packaged pharmaceuticals for placement in to shipping
containers.
. Assisted with cleaning and set up of all equipment.
. Used hand jack to move inventory to warehouse.
.
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