ANTON CHEREPACHE, P.E.

, RAC
202 MENDOCINO WAY
REDWOOD CITY, CALIFORNIA 94065
650-533-9765
ac798cec@westpost.net
SUMMARY
Results-oriented problem-solver with over three decades of diverse experience in
the medical device, pharmaceutical, and biotechnology industries. Held position
s in quality assurance, quality control, and quality management. In-depth knowle
dge of quality engineering, quality auditing, and drug and medical device regula
tions as evidenced by multiple certifications.
EXPERIENCE
Quality Consultant Redwood City, California
Lead Auditor 2010 to Present
Conducts supplier audits on behalf of clients such as Amgen, Abbott Laboratories
, and Johnson & Johnson.
Abbott Laboratories (contract) Redwood City, California
Supplier Quality Engineer 2009 to 2010
Conducted audits of raw material and component suppliers.
Investigated supplier-related problems.
Johnson & Johnson (formerly SurgRx) Redwood City, California
Senior Quality Engineer 2007 to 2009
As the Deputy Management Representative, chaired management review meetings.
Monitored all CAPAs to ensure that nonconformities were adequately addressed.
Responsible for the closure of all nonconforming material reports.
Developed specifications, test methods, and sampling plans.
Reviewed and dispositioned over 1,000 raw material lots.
Hosted regulatory audits and inspections.
Conducted internal and supplier audits.
Allergan (formerly Inamed) Fremont, California
Quality Systems Compliance Auditor 2003 to 2007
Led internal quality audits to ensure compliance with national and international
medical device regulations as well as ISO 13485 requirements.
Conducted quality audits of over forty raw material suppliers, testing laborator
ies, and distributors.
Verified the effectiveness of CAPAs implemented to address internal and supplier
audit nonconformities.
Conducted QSR and ISO training for all employees.
Underwriters Laboratories Santa Clara, California
Lead Auditor 1998 to 2002
Conducted over 300 preliminary, registration, and surveillance ISO 9000 audits o
f facilities primarily within the electronics, chemical, plastics, printing, and
medical device industries. Determined if new clients qualified for ISO certific
ation and if existing clients should retain their certifications.
Reviewed and verified the effectiveness of all CAPAs from previous audits.
Hitachi Chemical Diagnostics (formerly MAST Immunosystems)
Mountain View, California
Senior Quality Engineer 1997 to 1998
Created procedures and specifications for the inspection and testing of componen
ts and products.
Conducted quality audits of the companys instrument, reagent, and packaging supp
liers. Verified the effectiveness of CAPAs implemented to address audit nonconfo
rmities.
Determined the disposition of nonconforming products.
Cygnus Redwood City, California
Staff Quality Assurance Engineer 1992 to 1997
Conducted quality audits of the companys manufacturing, quality control, materia
ls management, and R&D functions to assess compliance with cGMP regulations, ISO
9002 standard requirements, and internal procedures.
Conducted quality audits of over seventy domestic and European manufacturers of
APIs, chemicals, and packaging materials. Responsible for the qualification of t
hese manufacturers as raw material suppliers.
Developed a computer database for scheduling internal audits, generating audit q
uestions, and tracking corrective actions.
Revised the procedures for handling controlled substances in order to bring them
into compliance with DEA regulations.
Established and managed the companys product compliant handling system.
Reviewed and dispositioned raw material and finished product lots.
Assisted with the review of the CMC section of NDA submissions.
Created or revised procedures and work instructions.
Provided cGMP training to over 400 employees.
Baxter Healthcare Valencia, California
Quality Engineer 1990 to 1992
Responsible for the orderly transfer, due to corporate restructuring, of all pur
chasing, production, and inspection documents pertaining to Baxters epidural ane
sthesia, respiratory therapy, and urinary product lines.
Reviewed and revised manufacturing and inspection documents and product labeling
.
Developed a computer database for tracking product changes.
Biogen Idec (formerly IDEC Pharmaceuticals)
Mountain View, California
Quality Assurance Specialist 1988 to 1990
Responsible for the management of the document control system.
Created or revised over 240 procedures and specifications.
Reviewed and dispositioned raw material and clinical product lots.
Bio-Rad Laboratories Hercules, California
Manufacturing Engineer 1987 to 1988
Responsible for the scale-up and transfer of new diagnostic reagents from R&D to
Manufacturing.
Trained manufacturing and quality control personnel to carry out new production
and testing procedures.
Created manufacturing and inspection documents.
Investigated and resolved problems with existing reagents and instruments.
Evaluated new vendors and components.
Conducted statistical analysis of experiments.
Sterling Biochemical Troy, Michigan
Diagnostics Formulation Manager 1985 to 1987
Trained and supervised eight technicians and operators engaged in the production
, testing, and storage of diagnostic reagents.
Selected suppliers and purchased chemicals and packaging materials.
Created or revised manufacturing and inspection documents.
Reviewed and dispositioned finished product lots.
Responsible for all communications with the FDA.
Cooper Biomedical (formerly Worthington Biochemical)
Freehold, New Jersey
Production Supervisor 1984 to 1985
Trained and supervised twelve employees engaged in the manufacture of diagnostic
reagents and two employees responsible for the preparation of containers and cl
osures.
Established statistical process controls.
Starting Materials Quality Control Supervisor 1983 to 1984
Trained and supervised eight technicians engaged in the testing of raw materials
and the inspection of packaging components.
Reviewed and dispositioned over 2,000 raw material lots.
Established sampling plans.
In-Process Quality Control Supervisor 1978 to 1983
Trained and supervised two in-process assay technicians and two filling/packagin
g line inspectors.
Released acceptable in-process lots and determined the adjustments required for
those lots not meeting specifications.
Revised assay procedures and specifications.
Quality Assurance Analyst 1974 to 1978
Analyzed statistical data in order to establish control serum ranges prior to ma
rketing.
Reviewed diagnostic reagent labeling for technical accuracy and regulatory compl
iance.
Conducted shelf-life and reconstituted stability testing of diagnostic reagents
and control sera.
Responsible for all quality control activities pertaining to the manufacture, te
sting, and packaging of APIs and parenteral pharmaceuticals.
Submitted 510(k) notifications to the FDA.
Calibrated laboratory instruments.
Investigated product complaints.
PROBLEM-SOLVING ACHIEVEMENTS
Problem: An in vitro diagnostics manufacturer had been rejecting a batch a week.
Solution: Refine and simplify the manufacturing and quality control procedures a
nd specifications, then conduct appropriate employee training.
Result: A 98% reduction in the number of rejected batches.
Problem: Another in vitro diagnostics manufacturer wanted to scale-up its manufa
cturing process so that larger volumes of a control product could be produced.
Solution: Re-engineer the entire manufacturing process.
Result: The products yield doubled while the time required to produce it decreas
ed by 75%.
Problem: A drug manufacturer had failed its first FDA pre-approval inspection.
Solution: Rigorously audit and re-audit all manufacturing, laboratory, and stora
ge areas. Conduct cGMP training for all employees.
Result: Three months later this manufacturer passed its next pre-approval inspec
tion.
Problem: A medical device manufacturer had received repeated audit nonconformiti
es from regulatory bodies regarding its customer complaint handling system.
Solution: Thoroughly revise all procedures and other documents related to compla
int handling. Automate and simplify the complaint review process. Obtain the nee
ded support at all levels of the organization to make the system fully functiona
l.
Result: Following the implementation of the re-engineered complaint handling sys
tem, audits conducted by two regulatory bodies found no nonconformities.
EDUCATION
B.A., General Science, Rutgers University, Camden, New Jersey.
PROFESSIONAL CERTIFICATIONS AND ACTIVITIES
Licensed as a Professional Engineer (Quality) by the State of California.
Served as a Subject Matter Expect to the California Board of Registration for Pr
ofessional Engineers and Land Surveyors from 1991 to 1998.
Senior Member of the American Society for Quality.
Certified Quality Engineer.
Certified Reliability Engineer.
Certified Manager of Quality/Organizational Excellence.
Certified Quality Auditor.
Certified HAACP Auditor.
Certified Biomedical Auditor.
Certified Pharmaceutical GMP Professional.
Served as a Subject Matter Expert in the development of the Certified Reliabilit
y Engineer, Certified Auditor, Certified Biomedical Auditor, and Certified Pharm
aceutical GMP Professional examinations.
As a Member of the ASQ Quality Press Standing Review Board, evaluates proposed m
anuscripts.
RABQSA-certified Quality Management Systems Lead Auditor. Scopes of certificatio
n include ISO 9001:2000 audits, ISO 13485:2003 audits, and ISO/IEC 17025:2005 as
sessments.
IRCA-certified Quality Management Systems Lead Auditor.
Canadian Medical Devices Conformity Assessment System Qualified Auditor.
Member of the Regulatory Affairs Professionals Society.
U.S. Regulatory Affairs Certified.
Canadian Regulatory Affairs Certified.
European Union Regulatory Affairs Certified.