Dennis Graber

Rochester, MI 48307
Cell Phone 248.561.9147
Email: dg130b2fa@westpost.net
Quality Professional
Dynamic * Leader * Visionary
I am an experienced quality professional possessing excellent business acumen in
cluding communication, problem resolution, and risk mitigation. Strengths inclu
de an ability to evaluate business needs and metrics, creative and dynamic team
player, able to build effective teams to achieve focused results and robust solu
tions. Able to provide practical quality management with excellent diagnostic a
nd non-conforming/CAPA investigation skills. Ability to serve as a catalyst for
cGMP and ISO compliance and employee accountability. Extensive experience work
ing in a FDA regulated aseptic environment (CFR 210/211). Vast experience worki
ng with pharmaceutical grade glassware and plastic primary components. Capable o
f establishing a rapport and credibility with diverse groups ranging from union
members to board members. Competitive drive whether it is sports or business.
Core Competencies
* Problem Analysis * Risked Based assessments * Communication
* Solution oriented * Entrepreneurial approach * Project Management
* Cross-functional * Process Improvement/Lean * Material Management
EMPLOYMENT HISTORY
JHP Pharmaceuticals - Rochester, MI
(JHP purchased facility in 2007, previous owners include King Pharmaceutical and
Warner Lambert)
* Senior Manager - Incoming Quality (Jan 2009 - Dec 2010)
* Continued to lead a team of quality inspectors and specialists, focusing on pr
ocess efficiencies regarding incoming components, their disposition and controls
.
* Hands-on involvement in daily operations and fire-fighting.
* Provide disposition of finished packaged product.
* Ensure drawing/SOP control
* Team leader on supplier management to ensure a predictable receipt of quality
materials. Initiatives consisted of the successful development of the following
programs:
* Quality and Supplier agreements with primary suppliers
* Supplier risk assessments
* Supplier Scorecards
* Supplier certification
* Created and executed inspector training sessions. Training focused on defect
identification and classification training on parenteral containers and closures
resulting in increased product yields (50% reduction of false rejection) and pr
oduct quality (reduced attribute failures from seven to one/year).
* Designed and tracked department metrics to ensure timely incoming component re
lease (averaged 99% for 2010), monitored work performance versus work standards,
and trended supplier compliance and defect root cause analysis.
* Transferred label control program into Incoming Quality Department which resul
ted in an increased efficiencies and decreasing facility headcount.
* Project Management - participant and mentor in three cross-functional projects
in the following areas:
* Plant Process Efficiencies - Utilizing lean principles the goal was to be able
to increase the number of batches by 25% without adding headcount to any depart
ment. My department was able to exceed the established goal of 40 hours/week in
efficiencies.
* Raw Material processing - focusing on material supply chain the cross-function
al team was able to significantly decrease raw material evaluations which increa
sed laboratory efficiency and site compliance.
* Inspection process - incorporated equipment to revamp manual inspection proces
s (implementing lean principles) which reduced line inspector headcount by 65%.
* Senior Manager - Quality Assurance (March 2006-Jan 2009)
* Project Management -To ensure ongoing development volunteered to lead a projec
t in Supplier Management. Initial focus pertained to supplier related defects t
hat had downstream impact to work efficiencies. Addressed issues with FMEA appr
oach.
* Added additional areas of quality oversight including bulk manufacturing, ster
ile filling operations, and departmental SOPs (editing or approval).
* Contract negotiation team member
* Perform internal/external audits.
* Initiate, review, and approve process or material change controls.
* Manager - Quality Assurance (January 2002-March 2006)
Supervisor - Quality Assurance (September 2000-January 2002)
Quality Assurance
* Manage the activities of the QA Specialist to ensure timely release of product
.
* Track and resolve customer complaints received from the field.
* Customer liaison relationship between the Quality Specialist and contract cust
omers.
* Manage deviation investigations to ensure a robust and timely evaluation.
* Approve intermediate and finished products based on batch record review to ass
ure compliance with cGMPs, compendia standards, and SOPs.
Statistical Quality Control
* Manage the activities of the Statistical Quality Control Department (salary an
d union) primarily focusing on inspection of components, raw materials, and on-l
ine attributes results.
* Defective component identification and problem solving
* Implemented and monitored quality standards and manufacturing process controls
.
* Responsible for the Defective Material Report system - ensuring timely resolut
ion of complaints related to non-conforming supplier components.
* Virus Vaccine Supervisor (February 1999-September 2000)
* Supervision of manufacturing activities
* Problem solving
* Senior Control Analyst (February 1998 - February 1999)
Control Analyst (March 1995-February 1998)
* Environmental monitoring in aseptic manufacturing environment
* Team leader - scheduling, training, communication
EDUCATION
Walsh College
Troy, Michigan
Master of Science in Management
Oakland University
Rochester Hills, Michigan
B.A. in Biology