Jerry Zacharatos

Stockton, CA ***** • 925-***-****

ad381t@r.postjobfree.com / ad381t@r.postjobfree.com /

Linkedin: https://www.linkedin.com/in/jerry-zacharatos-9a582a1b/

SENIOR QUALITY ASSURANCE & QUALITY CONTROL ENGINEER

Highly motivated and adaptable quality systems engineer with experience in biotechnology, IVD, and Medical Device industries. Effectively complete CAPAs, complaints, non-conformances, vendor controls, audit findings, and investigations. Extensive practical experience in method development and writing in a manufacturing work environment. Proven ability to integrate company’s documentation system into corporate documentation system via acquisition. Capable of handling multiple projects simultaneously and working independently.

• Excel, Formulas, Pivot Table, Vlookup • Outlook, and Access • ISO Train

• QAD, Minitab • 21 CFR Part 820 and Part 11 • MDSAP/ISO 13485/ISO 9001

• Internal Audits, Supplier Quality Audits • Oracle Database, SAP • QCBD and InfinityQS

• SOP, Batch Records, Test Records • Agile, Windchill • ExtraView, Sharepoint

• Specifications, Calibration Records • MS Office, Visio * Regulatory Affairs, FAO, WHO

* ISO-13485, ISO-14971, ISO-9001, CE * cGMP, GLP, GCP, GXP, CMC * IQ, OQ, PQ

* HACCP, ISO-22000, SQF-2000 * CAPA, Nonconforming, * FMEA, Root Cause Analysis

* Calibration, Metrology * Complaint Handling * 21 CFR 820, 803, 806

* 21 CFR 210, 211, 600, 610, 11, 58 * ISO-13485 Lead Auditor * ISO-11137 Sterility

ANALYTICAL CHEMISTRY 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, UPLC, 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., Flow Cytometry, Cell Cultures.

EXPERIENCE

FORMUREX, STOCKTON, CA February 2010 – Current

Sr. Quality and Regulatory Engineer (Pharmaceutical, Invitro Diagnostics, Medical Device)

Manages 5 direct reports and all quality and regulatory operations for the pharmaceutical facility. Provided support with receiving inspection, contract manufacturing, service, vendor control and calibration function, NCMRs, and CAPAs. Ensured compliance with quality processes. Evaluated MDR for each complaint. Provided quality training to all employees. Spoke quality background to IT team in order to help quality department to solve pharmaceutical documentation and record issues.

Reviewed and approved documents to ensure compliance with ISO 13485:2016 and 21 CFR Part 820 including GxP SOPs, work instructions, validation reports, quality batch records, change control forms, control of non-conformances documents, and training materials.

Closely worked with Purchasing Department regarding vendor control process.

Performed CAPA effectiveness verification and helped company to improve processes.

Created Pharmaceutical Software Master Copy (in Excel) for Operations.

Liaison between US team and China team.

ANALYTICAL CHEMISTRY-HPLC, HPLC-MS, UPLC, GC, GC-MS, ICP, ICP-MS.

Corning Life Sciences-Axygen, Inc., UNION CITY, CA June 2003 – February 2010

Sr. Quality and Regulatory Engineer (Medical Device and Invitro Diagnostics)

Managed document Control process in QCBD and internal audit programs. Recorded, monitored, and assisted QN (similar as CAPA) and task owners to complete corrective actions/preventive actions in SAP Quality Management module. Performed effectiveness checks to ensure the completion of CAPAs and close QNs. Monthly reported CAPA trend analysis results to upper management team. Supported the external audits and answered audit questions to external auditors.

Provided QM Master Data Support to SAP, such as QIR. Inspection Plan, Inspection Type, and etc. Written SAP Job Aids and conduct training of SAP Quality Management. Participated material enrichment UAT test.

Generated Quality Agreements upon customer requests. Reviewed, approved, and released FAI reports in QCBD and published records to Sharepoint.

Closely worked with Purchasing for vendor control program.

Quarterly performed proficiency test analysis and provided qualification of lab technicians’ pipette skills to Supervisors in Pipette Service Centers world-wide per ISO 17025 requirements.

Utilized multicultural skills to assist communication between US and China teams.

Reviewed and approved documents to ensure compliance with ISO 13485:2016 and 21 CFR Part 820 including GxP SOPs, work instructions, validation reports, quality batch records, change control forms, control of non-conformances documents, and training materials. Participated material enrichment UAT test.

Performed CAPA effectiveness verification and helped company to improve processes.

Created Software Master Copy (in Excel) for Operations.

Maintained and performed internal audit to ensure site quality systems compliance with ISO 13485 and 21 CFR part 820.

Power User of SAP DMS module for document control process.

Generated the Risk-based Internal Audit Schedules and the risk-based internal audit plans.

Generated Quality Agreements upon customer requests. Reviewed, approved, and released FAI reports in QCBD and published records to Sharepoint.

Closely worked with Purchasing Department regarding vendor control process.

Updated, reviewed and approved Quality Manual and SOPs in SAP DMS system

Responsible for assisting Company growth from $20 Million to $500 Million by working with all departments including manufacturing, purchasing, and Sales and Marketing.

Conducted QSR/GMP/ISO Risk Based Vendor and Internal Audits.

Provided QM Master Data Support to SAP, such as QIR. Inspection Plan, Inspection Type, and etc.

Maintained ISO 13485 & ISO 9001 Quality Systems including CAPA, Non-conformance, customer complaints, internal audit and supplier quality audit programs. Guided CAPA owners for root cause analysis and propose corrective action and preventive action plans.

Provided support with receiving inspection, contract manufacturing, service, vendor control and calibration function, NCMRs, and CAPAs. Ensured compliance with quality processes. Evaluated MDR for each complaint.

ANALYTICAL CHEMISTRY-HPLC, HPLC-MS, UPLC, GC, GC-MS, ICP, ICP-MS.

SYNPEP, INC., DUBLIN, CA March 2000 – June 2003

Sr. Quality Engineer. (Pharmaceutical, Medical Device, & Invitro Diagnostics)

Maintained ISO 13485 & ISO 9001 Quality Systems including CAPA, Non-conformance, customer complaints, internal audit and supplier quality audit programs. Guided CAPA owners for root cause analysis and propose corrective action and preventive action plans. Performed effectiveness check to ensure the completion of corrective actions and preventive actions. Quarterly generated Quality Metrics for Quality Management Review meetings.

Performed scheduled on-site Supplier Quality Audits and follow up with suppliers for audit corrective actions. Processed, reported, and tracked Supplier Corrective Action Reports (SCARs) in a timely manner.

Conducted QSR/GMP/ISO quality system internal audits per schedules. Assisted and scheduled customers’ and notified bodies’ on-site audits.

Owned document control process, revised and reviewed Quality Manual and SOPs, and integrated Particle Technology and IHC documents into Agile system.

Provided monthly QMS training to new employees and annually QMS training to companywide employees.

ANALYTICAL CHEMISTRY-HPLC, HPLC-MS, UPLC, GC, GC-MS, ICP, ICP-MS.

CERTIFICATIONS

Oriel Stat a Matrix certified ISO 13485:2003 Certified Lead auditor

EDUCATION

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

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

COVER LETTER

To: Hiring Manager

I’m looking for a Quality Engineer, Quality Specialist, or Analytical Chemistry Quality Control position in a Pharmaceutical, Medical Device, or Invitro Diagnostics Company. I can also manage or supervise quality department employees. I am Highly motivated and adaptable quality systems engineer with experience in biotechnology, IVD, Pharmaceutical, and Medical Device industries. I look forward to meeting you.

Kind Regards,

Jerry Zacharatos

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, GXP, 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, Engineer, Computer,

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