Kevin Holmes has over 30 years of experience in quality assurance and production supervision roles in the pharmaceutical and medical device industries. He has a proven track record of developing and enhancing quality systems to meet regulatory requirements. Currently he is a Team Lead/Production Supervisor at BD Diagnostics overseeing production operations and employee training. Previously he held roles with increasing responsibility at Biogen Idec, Eisai, and other companies involving quality testing, auditing, investigations, and ensuring compliance. He has a BS in Health Care Administration from Ashford University and education in electronic engineering technology.

1. Kevin Holmes
2032 Spring Creek Drive
Durham,NC 27704
kdholmes64@yahoo.com - (919) 530-1380
Individual with a proven quality and compliance judgmentalong with strong influential skills who possesses
leadership and general managementability,plus a track record of developing and enhancing qualitysystem
processes.Ability to develop, plan and execute long-term strategies to business needs while executing short
term requirements.
Proven record to develop, manage,execute and continuouslybuild qualitysystems to meetgovernmental
regulatory requirements,i.e.,cGMP-FDA 210 / 211
Authorized to work in the US for any employer
WORK EXPERIENCE
TEAM LEAD/ Production Supervisor
BD Diagnostics 2016-Present
Responsible for overseeing shiftoperations in the production ofcervical cancer screening kits through IVEC, ATS,
SERAC and Kitting production cells,employee training,retention and disciplinaryresponsibilities and performance
evaluations. Experienced in pharmaceutical qualitytesting and quality assurance,environmental monitoring,trending,
GMPs, method validations,laboratoryequipmentvalidations,compliance reviews,auditing,contamination control,
investigations,rootcause analyses,deviations,preventive actions,corrective actions,regulations,data analyses,
report generation,compendial methods,raw materials and productspecifications,stabilitystudies and product
release ofsterile and non-sterile formulations for large and small molecules.
QC Microbiology Associate/Lab Coordinator
Biogen Idec - Research Triangle Park,NC - 2008 to 2016
Responsibility:
Managed the EM start-up projectfor the addition ofthe P-6 suite which included protocol design,sample
site selection,institution,technical report writing,SOP updates and training ofaffected employees.Collection
of water samples thatinclude biobdurden,LAL, conductivity, TOC, heavy metals and nitrates from various
sample sites throughoutthe Manufacturing sector and adjoining buildings.Collects amples for environmental
air viability through the use of the SAS and Climetfor viable air and particulates.Designated as Certified
trainer for utility and facility monitoring and appointed new employee mentor.Testwater bioburden by way of
membrane filtration and water endotoxin through the Kinetic Turbidimetric method all in accordance to SOP's
and FDA standards.Testin-process samples for particulate matter using the Hyac particulate counter.Growth
promotion ofmedia types,confirmation of no contamination ofsamples through use ofthe BAC-T 3-D analyzer,
and testing of Biological Indicators.Participate in GMP data review and approval through usage ofNautilus
and Labware software.Initiate deviations and Lab Exceptions via trackwise.Upstream m anufacturing process
experience in cell culture and 15K.
Sr. Team Leader/Supervisor, Team Leader, Lead Technician, Technician
Eisai,Inc - Research Triangle Park,NC - 2001 to 2008
Responsibility:
Oversee OSD shiftoperations and technical staffto ensure maintenance ofdaily production goals;Coordinate
staffing activities including performance management,individual and group training and development,
compensation recommendations,staffmotivation and retention,recruitmentand new hire orientation;
Resolved complexmanufacturing issues as theyarose utilizing vast knowledge ofprocedures and operations;
Identified,analyzed, and initiated process and procedural improvements;Conducted investigations and
submitted deviation reports and created CAPA based on findings;Created and updated SOP's ;Reviewed
manufacturing GMP documentation through SAS for completeness,compliance and approval;Conducted
compliance audits in the manufacturing area.Participated in the OQ/PQ and validation of Fluid Air dryer and
Encapsulation machine and associated change controls.
Test Technician
Tec star Electrosystems - Durham,NC - 2000 to 2001
Responsibility:
Calibration and final testing of various aerospace and aircraftvalves in a non-magnetic environment;
Performance required skilled use oftestcages,calibration equipment,detectors and gauges;Performed inline
inspection and final buyoff of productbefore shipment.
Manufacturing Technician II

2. Bell and Howell Messaging Technologies - Durham,NC - 1998 to 2000
Responsibility:
Manufacture of various components thatwere necessaryfor the creation of Bell and Howell mail processing
systems;Provided testing for processed units and performed troubleshooting ofdefective subassemblies.
Shipping Supervisor
Owens and Minor - Raleigh,NC - 1993 to 1998
Responsibility:
Supervision ofa second shiftoperation;Assignmentofworkload and responsibilities for staffranging from
10-20 persons;Perform Qualitychecks and verification of computer orders to ensure accuracy of shipments
and overall compliance with shipping process;Monthly monitoring ofinventory; Monitor staff and provide
feedback on performance through reviews and evaluations;Maintain adequate staffing based upon work
volume
Team Leader
General Medical Corporation - Raleigh,NC - 1986 to 1993
Responsibility:
Co-supervision and mentoring offirst and second shiftemployees;Created manifests and order verifications
for shipping medical supplies to local,statewide,and out-of-state facilities;Implemented and monitored quality
control standards and procedures;Trained new personnel;Monitored progress ofstaffthrough performance
managementprocesses such as reviews and appraisals,meritand bonus awarding.
EDUCATION
BS in Health Care Administration
Ashford University - Clinton,IA Cum Laude
2012
Electronic Engineering Technology
Durham Technical CommunityCollege - Durham,NC
2000
NC State University - Raleigh,NC
1982 to 1985