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Manager Medical Device

Location:
Tracy, California, United States
Posted:
September 15, 2018

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Resume:

JERRY S. ZACHARATOS

**** ****** ***** *****, ********, CA 95206

925-***-****

ac612t@r.postjobfree.com / ac612t@r.postjobfree.com

OBJECTIVE Position(s) or Contract(s) at $1998 per month minimum (negotiable depending upon the position or contract) in establishing, developing, and/or managing QA/QC, laboratory, materials, biopharmaceuticals, bio-technology, food/nutrient/supplements, environmental/health/safety, regulatory affairs, legal and regulatory compliance, manufacturing, technical affairs, Business, Finance, and customer handling systems.

Keywords: quality, chemistry, biochemistry, chemist, biochemist, quality control, quality assurance, QA, QC, regulatory affairs, regulatory, compliance, analytical, laboratory, biotech, pharmaceutical, environmental, health, safety, petroleum, materials, polymer, manager, director, GMP, GLP, ISO, auditor, device, research, director, manufacturing, HAACP, food, nutrients, supplements, FDA, ICH, WHO, FAO, technical, CAPA, ER, Non Conforming, Exception Reporting, Root Cause Analysis and Determination Investigation, and Preventive Action, Validations (IQ/OQ/PQ), FMEA Investigations, Calibrations Systems

EDUCATION

B.S, Chemistry, Biochemistry, Organic Chemistry, Bioscience, Clinical Lab, Business, Law 1979

Southern Illinois University, Carbondale, IL/George Washington University, Washington D.C.

Additional Detailed Education & Training Information is Available.

*NOTE: SEE BOTTOM FOR COVER LETTER & ADDITIONAL SPECIFIC EXPERIENCE IN FOOD INDUSTRY*

PRIMARY SKILLS

Establishment, Development, and Management of Quality Assurance, Quality Control, Regulatory Affairs, Analytical Chemistry, Pharmaceutical and Biotech Manufacturing, food/nutrient/supplements, HAACP, GMP, GLP, ISO-9001/2008, ISO-13485:2003, CE, Regulatory Affairs, Technical Services, Environmental, Health, Safety, Auditing. Establishes and Manages QA/QC, laboratory, materials, biopharmaceuticals, Bio-Technology, environmental/health/safety, regulatory affairs, legal and regulatory compliance, manufacturing, technical affairs, Business, Finance, and customer handling systems.

30 + years of extensive CMC, cGMP/GLP/GCP, FDA and ISO and CE audits, CAPA, and implementation and development of entire QA/QC systems (including cGMP/GLP/GCP, ISO, EC, FAO/WHO, and ICH systems), HAACP, analytical/manufacturing/R&D development experience, ER, Non Conforming, Exception Reporting, Root Cause Analysis and Determination Investigation, and Preventive Action, Validations (IQ/OQ/PQ), FMEA Investigations, and Calibrations Systems

Very Strong Hands on Management Skills, Excellent People and Team Work Skills, Very Strong Training and Continual Improvement Skills, Focus and Expertise on Major Cost Reductions with Greatly Increasing Efficiency, and Major Strengths in Strongly Assisting Phenomenal Overall Company Growth (ie. In 6 years, I greatly assisted Corning-Axygen, Inc., to grow from a $20M to a $500M per year company) by working very closely with Manufacturing, Marketing and Sales, Design-Research-Development, all Levels of Management and Employees, and Customers. Very Strong Business Development Skills.

Quality Assurance and Quality Control Highlights:

30+ years Quality systems/ Assurance/ Engineer work experience in biotechnology, IVD, or Medical Device field.

Coordinate the effective completion of CAPAs, Complaints, NonConformances, audit findings, and Investigations. Collect data from multiple database systems for tracking and trend analysis. System administrator of QA software applications (QCBD and InfinityQS)

Extensive practical experience in method development and writing ISO 13485/ISO 9001/ISO 17025//21 CFR 820/ISO 14971 and SOP procedure in a manufacturing work environment. Certified lead auditor of supplier quality audit. Oriel Stat a Matrix certified ISO 13485:2003 Lead auditor

Excellent documentation skills in monitoring, enhancing and maintaining the controlled document system for Standard Operating Procedures, Batch Records, Test Records, Specifications for raw materials and finished goods, MSDS, and calibration records. Strong skills to integrate other company’s documentation system into the corporate documentation system via acquisition.

Power user of SAP Quality Management Module. Knowledge of Agile, TrackWise, MS office, Business Object, ISOTrain, LMS eLearning System

Capable of handling multiple projects simultaneously and working independently. Extremely dedicated, fast learner and highly self-motivated team player

CAPABILITIES & PROFESSIONAL EXPERIENCE

Analytical expertise with Mass Spectrometry (electrospray, "FAB", particle beam, chemical ionization, laser desorption, electron impact, APCI, & MALDI), NMR (high field NMR, proton, & Carbon-13 NMR), GC, HPLC, HPCE, SDS-Page, UV/VIS, ELISA, drug profiling, DNA/Protein sequencing/synthesis/ & purification, TLC, DNA probe, PCR, RT-PCR, mutagenesis, immunology, synthesis, microbiology, Endotoxin analysis, DSC, TGA, DMA, mechanical testing equipment, X-ray, monoclonal and polyclonal antibodies, atomic absorption, graphite furnace, ICP, flame emission, TOX, TOC, Carlo Erba, purge & trap, Buchii, apparatus, ion & pH probe, viscosity, particle size, FTIR & IR, titrators, electrophoresis radio immunoassay, enzyme immunoassay, gamma & beta counters, classical (wet) analytical methods, CD/ORD, amino acid analysis, open column (classical LC) for purification & analysis, biochemical & organic synthesis/ characterization/ & analysis, instrument repair & maintenance, environmental/ health/ & safety monitoring, ASTM/ EPA/ OSHA/ USP methods, protein crystallography and linear accelerator 3-D protein imaging, recombinant DNA, plasmids, kit development for sample purification and separation and cleanup.

Product development and manufacturing under TQM, GMP, GLP, & ISO 9000, 9001, 9002, 9004, 13485 (QSR for Medical Device similar to 21 CFR-820), 11137 (Sterility), and 17025 (Laboratory Certification) requirements; 21 CFR-11, 210, 211, 600, 610, 800’s (Medical Device), and 820; and CE, MDD, & IVD; 21CFR-120 & 123 (HAACP), 110, & 100 Series (Food);

30+ years experience in clinical diagnostics, medical device, chemical, pharmaceutical, medical, biopharmaceutical, environmental/ health/ & safety, petroleum, & agricultural chemical industries. Companies include: Chevron, Corning Life Sciences, Bio-Rad Laboratories, East Bay Dishargers Authority, Shaklee/Yamanuchi Pharmaceuticals, Tri-Valley Growers, Core Laboratories (Saybolt), SynPep, Axygen, and U.S. Navy (See below for details).

Polymer, composite, materials, small molecule, monomer, dye, resin, protein, DNA, peptide, protein, antibody, carbohydrate, petroleum, & agricultural chemical characterization & synthesis. Diagnostic kits.

Management and supervision experience. Professional licensure as a California Medical Laboratory Technologist from 1978 to 1982. Professional licensure as a California Waste Water Laboratory Analyst 3.

Procedure/protocol development & implementation.

Failure mode analysis & Risk Assessment, process troubleshooting & improvement, technology transfer, process plant scale up, formulations, bio & organic synthesis, & determinations of chemical mechanisms.

SOP's, analytical method development & validation, & clinical trials under GMP, GLP, ISO-9000, 9001, 9002, and 13485 requirements.

QA audits, QA/QC, regulatory affairs and compliance, FDA & EPA interface, quality circle meetings, IND, NDA, 510(k), PMA (Pre-Market Approval Application), In-Vitro Diagnostics, Medical Device, IDE (investigational device exemption), and PDP (Product Development Protocol).

Complete computer literacy & programming including: IBM (DOS systems) & Macintosh based systems, Lotus 1-2-3, Word Perfect, D-Base, Windows, FORTRAN, Basic, PL-1, C, Idris, COBOL, EXCEL, Cricket Graph, MacWrite, Word, MacDraw, Claris File Maker Pro, MAS-90, MS-DOS, UNIX systems (Motorola CPU's), "Apple Talk" networks, Novell LAN networks, Power Point, Access, all Microsoft Software including Windows 7 and Vista, all Mac based Software, and HTML and web design and development experience with TOP RANKING web sites with Marketing and Sales Development and Growth.

EMPLOYMENT EXPERIENCE

Consultancy Owner-Quality, Business, Laboratory, Finance, Legal, & Technical: 02/10-Present

Establishes from absolute beginning, troubleshoots, improves to the existing business model, audits, and establishes procedures and protocols for all Quality Systems (ISO-13485, 9001, 17025, 11137, 22000, etc.; 21 CFR 210, 211, 600, 610, 820, 108, 110, 113, 114, 120, 123; HACCP; FAO/WHO Guidelines; CE; ICH Guidelines; TQM; and all other Quality Systems); Regulatory Systems (510(k), PMA, IND, NDA); Laboratories (Analytical, R&D, Biotech, Biological, Bioassay, Industrial, Microbiological Labs, and all other similar types of Labs); and Business, Legal, and Finance Systems.

30+ years Quality systems/ Assurance/ Engineer work experience in biotechnology, IVD, or Medical Device field.

Coordinate the effective completion of CAPAs, Complaints, NonConformances, audit findings, and Investigations. Collect data from multiple database systems for tracking and trend analysis. System administrator of QA software applications (QCBD and InfinityQS)

Extensive practical experience in method development and writing ISO 13485/ISO 9001/ISO 17025//21 CFR 820/ISO 14971 and SOP procedure in a manufacturing work environment. Certified lead auditor of supplier quality audit. Oriel Stat a Matrix certified ISO 13485:2003 Lead auditor

Excellent documentation skills in monitoring, enhancing and maintaining the controlled document system for Standard Operating Procedures, Batch Records, Test Records, Specifications for raw materials and finished goods, MSDS, and calibration records. Strong skills to integrate other company’s documentation system into the corporate documentation system via acquisition.

Power user of SAP Quality Management Module. Knowledge of Agile, TrackWise, MS office, Business Object, ISOTrain, LMS eLearning System

Capable of handling multiple projects simultaneously and working independently. Extremely dedicated, fast learner and highly self-motivated team player.

MOST RECENT & NOTABLE CONSULTANCIES ARE:

Formurex, Inc. (Stockton CA.), & Pacific Pharmaceutical Services, Inc. (Reno, Nevada)-In Association With Cedarburg Hauser Pharmaceuticals, Nektar, InterMune, Spectrum Pharmaceuticals, Johnson & Johnson, Metabolex, & A Number Of Other Companies. SEE DETAILS BELOW:

Director of QA/QC, Regulatory Affairs, Legal, Technical Services, & Analytical Services 02/10-Present

Formurex, Inc. & Pacific Pharmaceutical Services are pharmaceutical contract research & manufacturing organizations (CRMO) with a mission to provide the best services in API Development and Manufacturing, Pre-formulation, Formulation Development, Research, Analytical, Stability and GMP Manufacturing. Established, Directs, and Manages all aspects of Quality Assurance, Quality Control with regard to Compliances of 21 CFR 210/ 211/ 600/ 610, 820, 58 (GLP), ISO-13485, ISO-17025, DEA Controlled Substances, and up to Category 4 Potent and Cytotoxic Drugs in Capsule, Powdered, Tablet, Spray, Liquid, Emulsion, Inhalation, Injectable Forms, and Clinical Distribution and Storage.

*NOTE: I TOOK EARLY RETIREMENT FROM CORNING (BELOW) TO ESTABLISH THIS CONSULTANCY COMPANY*

Corning Life Sciences-Axygen, Inc., Union City, California 06/03-02/10

Quality & Technical Systems (Laboratories) Manager & Director

Established, managed, and directed all aspects of corporate quality assurance/control, regulatory affairs, technical affairs, and analytical functions (for microbiology (including genetic, cell biology, microbial, sterility) and analytical) medical device, diagnostic kit(s), and other manufacturing (plastic consumable laboratory supplies) including: ISO-9001:2008 certification, ISO-13485:2003 certification, CE, FDA registration, cGMP/GLP compliance with respect to manufacturing, R&D, and quality control; regulatory affairs, Environmental/Health/Safety, audits (regulatory, customer, and management inspections) training, technical support for customers and internal staff, documentation, document control, validation, establishment and enforcement of acceptance and release criteria, inspection management, discrepancy management, technical services (including extensive analytical and technical and product development work), overall compliance, bulk lot release, master change control, compliance with individual customer requirements with respect to 510(k), PMA, In-Vitro Diagnostics, Medical Device, IDE, and PDP submissions, marketing and regulatory body (including ISO Registrars, FDA, EPA, and OSHA) interface.

SynPep Corporation, Dublin, CA 03/00-06/03

Quality Assurance & Control, Regulatory Affairs, Technical & Analytical Services Manager

Established and direct all aspects of corporate quality assurance/control, regulatory affairs, technical affairs, and analytical functions for peptide, antibody, and bulk biopharmaceutical manufacturing including: ISO-9001:2000 certification, FDA registration, cGMP/GLP compliance with respect to manufacturing, R&D, and quality control; regulatory affairs, Environmental/Health/Safety, audits (regulatory, customer, and management inspections) training, technical support for customers and internal staff, documentation, document control, validation, establishment and enforcement of acceptance and release criteria, inspection management, discrepancy management, technical services (including extensive analytical and technical development work), overall compliance, bulk lot release, master change control, compliance with individual customer requirements with respect to IND and NDA submissions and clinical trials, marketing and regulatory body (including ISO Registrars, FDA, EPA, and OSHA) interface. Manage QA/QC, Purification, Shipping, and Lyophilization Departments.

City of San Leandro, San Leandro, CA 04/94-06/97

Technical Services/Laboratory Manager

Managed 3 environmental laboratories, environmental compliance, QA/QC, health, safety, regulatory agency permitting and reporting, and licensing affairs for the San Leandro Water Pollution Control Plant and the East Bay Discharge Authority, and manage 20 staff members.

Established the entire QA/QC protocol and Standard Operating Procedures for analyses, safety, reporting, and data tracking required for EPA and State of California licensure and permits.

Bio-Rad Laboratories, Richmond, CA 03/91-06/93

Senior Scientist: Analytical, R & D, & QA/QC Services

Performed advanced analytical development and analysis for Analytical, EH&S, R&D & QA/QC divisions of Bio-Rad Laboratories Corporation.

Developed & improved procedures & facilities for polymer, composite, materials, monomer, dye, resin, protein, DNA, drug, & carbohydrate characterization & synthesis. Diagnostic kits.

Established new testing facilities & methods development for environmental, health & safety monitoring of soils, hazardous waste, fugative air emissions, & waste water.

Established corporate QA/QC & analytical protocol guidelines utilizing "GMP", "GLP", "SPC", ISO-9000, and Regulatory Affairs with FDA, OSHA, & EPA.

Chevron Chemical Company: Richmond, CA 04/81-03/91

Senior Scientist: Analytical, R & D, & QA/QC Services

Performed advanced analytical development and analysis for Analytical, R&D, EH&S, & QA/QC Services for Chevron Chemical Corporation.

Developed & improved procedures & facilities for Polymer, composite, materials, monomer, dye, resin, petroleum, pharmaceutical, & agricultural chemical characterization & synthesis.

Established new testing facilities & methods development for environmental, health & safety monitoring of soils, hazardous waste, fugative air emissions, & waste water.

Established corporate QA/QC & analytical protocol guidelines utilizing "GMP", "GLP", "SPC", ISO-9000, and Regulatory Affairs with FDA & EPA.

U.S. NAVY 04/75-04/81

Research Coordinator

Directed 13 research laboratories, staffed with 40 civilian staff members, involved with biochemistry, endocrinology, internal medicine, pharmacology, organic chemistry, inorganic chemistry, molecular biology, immunochemistry, & enzyme research. Research papers were published.

Consultancy Experience-Self Employment

Core Laboratories, Martinez, CA 12/99-03/00

Chemist

Perform routine testing, development of analytical and QA/QC protocols, and manufacturing and customer support (problem solving) involving petroleum products.

B. YLA Inc., ADVANCED COMPOSITE MATERIALS, Benicia, CA. YLA Inc., ADVANCED COMPOSITE MATERIALS, Benicia, CA 08/98-01/99

Consultant/ Private Contractor QA/QC Chemist

Perform routine testing, development of analytical and QA/QC protocols, and manufacturing and customer support (problem solving) involving advanced composite materials, resins, films, and adhesives.

Developed analytical protocol, utilizing FTIR, for the qualitative and quantitative determination of proper resin and cured laminate manufacture and performance.

Lab Support, Sacramento, CA 06/97-08/98

Consultant: Analytical & QA/QC Development

Research and Development of complete analytical and QA/QC protocols for different clientele, including Tri-Valley Growers in Modesto, CA.- Researched and Developed analytical protocols for the determination of Phenolic compounds in olives (Oberti Olives) and production methodologies to reduce the Phenolic contamination of the olives. One half of the national supply of olives was quarantined. The project was successfully completed.

Biozone Laboratories, Pittsburg, CA 02/94-02/95

Consultant: Analytical & QA/QC Development for Pharm, Nutrient, & Topical Formulations Manufacturing

Developed complete analytical & QA/QC protocols for O.T.C. pharmaceutical, nutrient, cosmetic, topical formulations, & Liposome manufacturing.

Established complete analytical/R&D laboratory.

Abco Laboratories, Concord, CA 07/94-08/94

Consultant: Analytical & QA/QC Development for Pharmaceutical & Nutrient

Manufacturing

Developed complete analytical & QA/QC protocols for O.T.C. pharmaceutical, nutrient, & cosmetic manufacturing.

Shaklee/Yamanuchi Pharmaceutical Corp., Hayward, CA. 03/94-04/94

Consultant: Analytical & QA/QC Development for Pharmaceutical Manufacturing Startup

Developed analytical & QA/QC protocols for O.T.C. & prescription pharmaceutical manufacturing startup.

Ischemia Research Foundation, San Francisco, CA 2/93-01/94

Consultant: Clinical Trials

Performed clinical trials for Farmos & Gensia pharmaceutical companies utilizing "Acadesine" during surgical procedures involving Ischemic patients for final phase FDA approval.

Established complete QA tracking program for the "Acadesine" clinical trials.

References and reference materials (publications, S.O.P.’s, performance evaluations, etc.) available upon request.

FOOD EXPERIENCE:

Throughout my career in Quality Assurance & Quality Control, I have performed consulting work with full-time employment resulting in Overall 15 years experience with foods (Produce, Dairy, Meat, Feeds, Grains, nutrients, supplements, Agricultural Chemicals and Fertilizers, etc.). I put together a list of companies, extracted from my resume, at which I have done consulting and full time employment work related to the food industry:

Chevron Chemical- (04/81-03/91)-Developed, Established, and Fully Implemented QA, QC, Compliance, Regulatory, and Laboratory Procedures, Protocols, Processes, and Systems for Produce, Feeds, Grains, Agricultural Chemicals.

Tri-Valley Growers- (Lab Support)- (06/97-08/98)- Developed, Established, and Fully Implemented QA, QC, Compliance, Regulatory, and Laboratory Procedures, Protocols, Processes, and Systems for Produce, Dairy, Meat, Feeds, Grains, etc.,

Biozone Laboratories-(02/94-02/95)- Developed, Established, and Fully Implemented QA, QC, Compliance, Regulatory, and Laboratory Procedures, Protocols, Processes, and Systems for Produce, Dairy, Meat, Feeds, Grains, nutrients, supplements, etc.,

Abco Laboratories-(07/94-08/94)- Developed, Established, and Fully Implemented QA, QC, Compliance, Regulatory, and Laboratory Procedures, Protocols, Processes, and Systems for Produce, Dairy, Meat, Feeds, Grains, nutrients, supplements, etc.,

Shaklee- 03/94-04/94- Developed, Established, and Fully Implemented QA, QC, Compliance, Regulatory, and Laboratory Procedures, Protocols, Processes, and Systems for Produce, Dairy, Meat, Feeds, Grains, nutrients, supplements, etc.

COVER LETTER:

TO: Hiring Manager

I am seeking Positions and/or Contracts at $1998 per month or less (depending upon the position or contract) in establishing, developing, and/or managing QA/QC, laboratory, materials, biopharmaceuticals, bio-technology, food/nutrient/supplements, environmental/health/safety, regulatory affairs, legal and regulatory compliance, manufacturing, technical affairs, Business, Finance, and customer handling systems. I am willing to relocate, if necessary. It is rather easy for me to do. My salary requirements are negotiable, am willing to relocate and travel. I may be reached at 925-***-**** and my e-mail is ac612t@r.postjobfree.com. I had taken offered & available early retirement from Corning (02/2010) & established a successful fulltime Consultancy for Quality, Business, Laboratory, Finance, Legal, & Technical Projects. I look forward to hearing from you. Regards, Jerry Zacharatos.



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