TONY MCKELVEY

Tracy, California 661.755.3835 tonymckelvey@att.net

CAREER SUMMARY
Quality Assurance professional with over 22 years experience, successfully integrates background in machinery processes and
manufacturing flow in pursuit of bottom-line goals and objectives. Continuously drives process improvement and product
enhancement by eliminating and reducing failures, errors, and defects. Excellent work ethic, highly adaptable, and capable of
delivering results in both individual and team-oriented environments.

Certified Quality Auditor (ASQ)

Six Sigma Black Belt
Manufacturing Engineering Certificate
HACCP and FSMA
Better Process Control School
Co-author and co-inventor of a Pending Patent for a CoQ10 Formulation and Process
Adept at reading, analyzing, and interpreting technical specifications, codes and regulatory requirements (21CFR parts 110,
111, 210, 211, and Q7A), and quality data
Author and reviewer of Standard Operating Procedures, work instructions, laboratory procedures, and safety procedures to
comply with cGMP and GLP regulations

PROFESSIONAL EXPERIENCE
GHIRARDELLI, San Leandro California 2015 to 2017
Contract Manufacturing Food Safety Manager
Ensure all Co-manufacturers and Co-packers meet all regulatory and Ghirardelli requirements.
Work with Co-manufacturers and Co-packers to improve performance and reduce customer complaints.
Managed annual audits and vendor compliance of Ghirardellis regulations.
Served as Technical Quality and Food Safety leader for Trials and first productions runs with Co-manufacturers and Co-
packers.

SAFEWAY CORPORATION, Pleasanton, California 2011 to 2015

Supplier Quality Manager, Quality Assurance and Consumer Protection
Inspect, audit and certify supplier facilities for compliance with sanitary, regulatory, production, and QA requirements.
Ensure product quality is in compliance with Safeway, federal, and state regulations and interact with appropriate
representatives.
Work with vendors for Continuous Improvement by assessing process capabilities to reduce customer complaints by 20%.
Work closely with Marketing and Sourcing to insure timely completion of new introductions and existing products/ New
Vendor approval projects.
Conduct and manage the third party vendor audit program for assigned vendors.

JM HUBER, Modesto, California 2008 to 2010

Quality Manager, Huber Engineered Materials, Nutrition Division
Managed the quality of all manufactured existing products and 20 new ones, and compliance with regulatory standards
resulted in passing all customer and Regulatory audits.
Directed and coordinated three shifts of the Quality group to monitor and enhance the quality of the products.
Increased regulatory environment to a 21CFR 211 standard (Drug Manufacturing).

LEINER HEALTH PRODUCTS, INC., Valencia, California 2000 to 2008

Senior ScientistTechnical Operations 2007 to 2008
Identified, assessed, and recommended new and distinct processes and products for the Operations Group.
Introduced and implemented a gelatin recovery system for an annual cost savings of $1,200,000.
Assisted in optimizing existing processes to utilize new raw material and reduce annual gelatin manufacturing costs by
$700,000.

Quality Assurance / Quality Control Manager 2000 to 2007

Reduced dock to stock time for finished products from 57 to 16 days.
Managed three shifts of the quality assurance group. Directed and coordinated quality control programs to ensure continuous
production of high-quality products consistent with established standards.

1
 Developed and analyzed statistical data and product specifications to determine present standards and quality and reliability
expectancy of finished products, reduced fill weight for an annual cost savings of $450,000.
Performed testing of finished products to measure product performance under a variety of conditions, and documented the
results of the test.
Investigated and adjusted all customer complaints, reduced number of complaints by 17%, and the response time from 48 to
21 days.

CAPTEK SOFTGEL INTL, INC., Cerritos, California 1999 to 2000

Quality Assurance Manager
Liaised with production supervisors and operators during quality system development and audits to develop standardized
procedures and improvement opportunities in manufacturing various products.
Directed the activities of three shifts of the quality assurance group to control in process manufacturing, finished products,
and GMP documentation.

COSMETICS LABS (A Division of ALBERTO CULVER), Chatsworth, California 1998 to 1999

Quality Assurance / Quality Control Manager
Supervised three shifts of chemists. Tested raw materials, in process, and finished samples to ensure that customer
requirements and FDA guidelines were consistently met.
Assisted in process improvement as well as in devising new test methods.

CAPTEK SOFTGEL INTL, INC., Cerritos, California 1996 to 1998

Quality Control Manager
Set up laboratory testing for start-up manufacturing company. Implemented testing procedures for analytical and
microbiological testing.
Worked with Manufacturing to ensure proper handling of raw materials and overage if needed to meet label claims.

ALPHA THERAPEUTIC CORPORATION, Los Angeles, California 1992 to 1996

Scientist IIDepartment of Research and Development
Helped in protocol development and ongoing assessment of safety and pharmacovigilance, interpretation of clinical data, and
completion of final reports.
Monitored, conducted research, and worked on plasma-derived products to prevent the adverse effects of various medicines
to patients, both in long-term and short-term side effects.

UNIVERSITY OF CALIFORNIA, Los Angeles, California

Research AssistantDepartment of Microbiology and Immunology
Actively involved in the study of latency of herpes simplex virus.
Performed In situ hybridization studies to locate site of murine cytomegalo virus, as well as determine the molecular basis of
latency of herpes simplex type I virus.

GEORGETOWN UNIVERSITY HOSPITAL, Washington, D.C.

Research AssistantPediatric Research Laboratory
Analyzed and studied dopamine and beta adrenergic receptors in the kidney by working on membrane purification and
radioligand binding assays.
EDUCATION / FORMAL TRAINING
Bachelors in Biochemistry/Molecular Biology, University of California, Santa Barbara, California
Graduate Courses in Biochemistry, Georgetown University, Washington, D.C.
Six Sigma Black Belt, Manufacturing Engineering Certificate, UCLA Extension School of Engineering, Los Angeles,
California
SELECTED PUBLICATIONS
W. Harel, T. McKelvey, R. Mamidi, P. Battacharya, Y. Uemura. Alpha Therapeutic Corporation, Los Angeles, CA. Lack of
inhibitory effects on cell proliferation by high-purity coagulation factor VIII concentrates. Blood 1993, Vol. 82, Supplement 1, p
62A, Abstract #235.

W. Harel, T. McKelvey, R. Mamidi, Y. Uemura, (SPON, SL Norton). Alpha Therapeutic Corporation (ATC), Los Angeles, CA
90032. Intravenous immunoglobulin - G (IGIV) preparations contain high-titer antibodies to bacterial exotoxin super antigens.
Journal of Immunology 1993, Vol. 150, Issue #8 part 2, p 133A, Abstract #1334.

Felder CC; McKelvey AM; Gitler MS; Eisner GM; Jose PA. Dopamine receptor subtypes in renal brush border and basolateral
membranes. Kidney International, 1989 Aug, 36(2):183-93.