Quality Control Manager
Resume:
***** ******: 732
cterpak@comcast.n
et
Chris Terpak
Summary Over twelve years of progressive management
positions with a proven track record of leading
Quality Assurance/Quality Control teams in a cGMP
environment. In depth knowledge of US FDA cGMP (21
CFR 210, 211 & 820), ICH Q7A and the ISO 9001:2008
Quality Management Standard. Proven ability to
communicate quality policies and objectives to all
levels of the organization and to interact with
suppliers, customers and regulatory agencies.
Work experience Spectrum Chemicals and Laboratory Products, New
Brunswick, NJ
Director of Quality, January 2007- present
Develops, implements, and directs quality systems
in a manner compliant with ICHQ7A, FDA cGMP (21CFR
210, 211 & 820) and all global regulatory
requirements
Member of Senior Management Team, which provides
executive guidance for the entire organization
Develops and implements Key Quality Performance
Indicators to measure, monitor, trend and improve
organizational quality functions
Develops and implements corporate Quality Policies
and Objectives
Responsible for senior leadership, mentoring and
supervision of entire Quality Unit
Serves as primary contact for and the conduct of
customer and regulatory audits (including US FDA,
US DEA, US DOT, NJ DEP)
Leads investigations into and resolves potential
quality issues to improve organizational efficiency
including Management of Change, Change Control and
Deviation Management
Facilitates improvements throughout the
organization to ensure operational excellence while
maintaining strict compliance with cGMP standards
Developed and directs organization's Annual Product
Review for all Active Pharmaceutical Ingredients
Manager of Quality and Operations, March 2004 -
January 2007
Review and maintain facility's Standard Operating
Procedures and Work Instructions
Responsible for assuring continued compliance of
operations to cGMP (21 CFR 210, 211 & 820, ICH Q7A)
and ISO9000 standards
Developed and implemented company wide
Corrective/Preventive Action (CAPA) Program
Supervised facility stability testing program for
Active Pharmaceutical Ingredients
Developed and implemented corporate Method
Development and Validation protocols
Perform Management Reviews and present findings to
Upper Management
Developed and maintained facility's Security and
Emergency Response Plan
Manage budget of facility's Quality Control/Quality
Assurance departments
Quality Control Manager, January 1999 - March 2004
Perform investigations on Out of Specification
materials
Responsible for all Quality related aspects of East
Coast Operation
Responsible for cGMP training of all employees
Maintain facility's ISO9000 certification and act
as Management Representative for East Coast Plant
Coordinate and conduct supplier and internal audits
Implement benchmarking program and quality
improvement program to reduce error rate by 35%
Quality Control Supervisor, March 1998 - January
1999
Knowledgeable in various analytical techniques
including USP/NF, FCC, BP, EP, JP and ACS
methodologies
Responsible for the daily operations of Quality
Control Analytical Laboratory
Coordinated the release of raw materials to
production
Facilitated and coordinated fulfillment of
customer's special requirements
Developed matrices to measure productivity of
Quality Control laboratory
Responsible for calibration program for all
critical laboratory equipment
Responsible for finished product release
Quality Control Chemist, August 1997 - March 1998
Responsible for testing of incoming raw materials
to compendial specifications
Coordinated the production of standardized
solutions for resale
Responsible for ensuring the quality of and
releasing special customer orders
Instrumental expertise on FTIR, GC, AA/FE, HPLC,
UV-Vis Spectrophotometer, Karl Fisher Autotitrator,
Polarimeter, Viscometer, Refractometer, Autoclave,
and Total Organic Carbon Analyzer
Education University of Scranton Scranton, PA
Master of Science, Clinical Chemistry, July 1997
Bachelor of Science, Biology, May 1994
Professional American Chemical Society member, American Society
affiliations for Quality senior member, HAZWOPER first responder
certified
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