837 MAIN ST.

* APT E * BELLEVILLE * NEW JERSEY * 07109

973-687-8778 * 973-302-4833
dbd47404@westpost.net
DAVION BUCHANAN
OBJECTIVE
Acquire a position within the quality/regulatory industries that continue to app
ropriate my professional work experience and education.
SUMMARY OF QUALIFICATIONS
* Released Phase 1 Drug batches and batch records.
* Managed high level research and manufacturing projects with senior management
and upper staff level colleagues.
* Validated equipment and process protocols according to analytical, federal and
company guidance's.
* Facilitated innovative techniques to improve batch disposition turnaround time
.
PROFESSIONAL EXPERIENCE
Enzon Pharmaceuticals, Inc., Piscataway, NJ 06/09- 02/10
Specialist, R&D Compliance
* Audit inspection findings performed on third party manufacturers for good manu
facturing practices (GLP), good laboratory practices (GLP) and good clinical pra
ctices (GCP).
* Review regulatory and clinical submissions using federal and corporate guidanc
e.
* Perform Installation, Operation and Performance Qualifications according to Qu
ality Management Protocols.
* Release finished product pharmaceutical campaigns for sale into commerce.
* Revise standard operating procedures (SOP), audit plans, clinical protocols an
d stability protocols for adherence to regulatory, company and product guideline
s.
* Review Certificate of Analysis, analytical data, and calibrated equipment to d
etect and prevent any results out of specifications (OOS).
* Prevent deviations by reviewing and revising corrective and preventive action
plans (CAPA's).
Abbott Laboratories/Kos Pharmaceuticals, Edison, NJ
7/04 - 02/09
Quality Assurance Auditor II/ Production Technician I
* Initiate and review notice of events (NOE's), deviations, change controls, and
out of specifications
(OOS) using the Trackwise Quality Management Software System.
* Disposition of raw materials, components and finished pharmaceutical product u
sing JDEdwards People Soft Inventory Management System.
* Use of Good Manufacturing Practices (GMP's), Standard Operating Procedures (SO
P's)
and specific batch record formulations for manufacture of solid dosage and
inhalation products.
* Perform room releases, manufacturing line clearances, in- process testing, cal
ibrations and equipment clearances as required by applicable federal and company
guidance.
* Provide training for new hires and troubleshooting for manufacturing and quali
ty issues.
Amersham Health Science, South Plainfield, NJ
7/02 - 07/04
Production Technician II
* Process, dispense, assay and package radio-chemicals and radio-pharmaceuticals
according to current
Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP'
s) and applicable
policies.
* Preparation and set up of required equipment and materials according to regula
ted safety
requirements.
* Assist in training initiatives and solve routine manufacturing problems to acc
urately complete all
batch records and related documentation.
Teva Pharmaceuticals USA, Fairlawn, NJ 4/00 - 3/02
Process Engineer Technician
* Assist Process Engineers with conducting equipment and manufacturing process c
hange control
studies and conducting Alternate Raw Material Supplier Qualification Studi
es.
* Assist Process Engineers with troubleshooting routine production and manufactu
ring failure investigations.
* Preparation of documents to support technical projects and regulatory submissi
ons for Engineering and Regulatory Affairs.
* Assist process engineers in preparation and revision of Master Formulas and Ba
tch Records and their concurrent new and existing process characterization batch
es.
Novartis Pharmaceuticals, East Hanover, NJ 11/97 - 9/98
Laboratory Technician - Clinical Product Development Department
* Operate and perform maintenance on various product development and clinical ma
nufacturing equipment.
* Weigh and mix raw materials according to SOP's, USP and Material Safety Data S
heet (MSDS).
* Maintain GMP and Quality Assurance in all Quality Control and International Sa
fety Operations.
Hoffman- La Roche Pharmaceuticals, Nutley, NJ 6/89 - 9/97
Laboratory Technician II
* Inspection of raw materials and packaging components.
* Review and problem solve complaints regarding specifications and compliance is
sues for quality control.
* Administrative and technical Support to complete routine and non routine labor
atory testing.
EDUCATION
Essex County College, Newark, NJ 1986 - 19
88
Associate of Science- Computer Science
TECHNICAL KNOWLEDGE
Microsoft Windows Operating Systems, Microsoft Word, Microsoft PowerPoint, Micro
soft Excel, Microsoft Access, Microsoft Outlook, Lotus Notes, Remote Manipulator
s, Autoclave & Pyrogen Oven, Pneumatic Lifts and Drills, Digitmatic Calipers, Ul
tra Violet Lights.
CERTIFICATES
Confirmed ISO 9002 Certified.
Certificate for Pharmaceutical Quality Assurance and Control (2008)
Certificate for Inspection of Batch Records (2007)
AFFILIATIONS
CFPH, The Center for Professional Advancement (2008)
ASQ, American Society for Quality (2007)
PTI International (2007)