Biotech QC/QA Lead with Auditing Expertise

Marc Elias

Massachusetts *****

Phone: 508-***-****

********@*****.***

Objective: Seeking a position in Biotech/Pharma in QC: HPLC Expert resolving & troubleshooting analysis, procedures review, LIMS, Lab Audit, QC Data Reviewer, 5S, remediate lab issues, results oriented. Also seeking QA/ Documentation, GxP Quality Auditor, Master Batch Record Reviewer (EBR / MBR) & corrective actions, Develop Solutions, Remediations, Gap Analysis. Project Management and other management or non-management level positions. Available for Remote, Hybrid, onsite position or mix. Summary:

• Experience in resolving QC and QA related to manufacturing of biopharmaceuticals and pharmaceuticals. Also, remediate issues. Good knowledge of FDA, EMEA and other applicable industry and quality regulations. Some experience on medical devices.

• Over two decades of hands-on experience and results oriented in Quality Management System, QC / QA / QMS and documentation practices in GMP environment

(Biotechnology, Biopharmaceuticals and Pharmaceuticals). Details oriented; results driven. Thrive in fast pace environment, CRO, CLO & CMO, multidisciplinary environments.

• Strong Auditing and remediation experience vs ISO9001 and support Continuous Improvement initiatives programs, and project management. Great experience in Drug Product / Drug Substance.

• Right First Time (RFT) practices to reduce the waste/rejection and efforts and increase efficiency and applying

“OPEX/Lean/Six Sigma, DMAIC”. Used statistical system DARA. Risk Management and Assessment.

• Adaptable, flexible and able to work under high pressure and fast pace environment. Dealing with customer complain issues and resolutions. Also, I have excellent interpersonal, communication, negotiating, influencing, and collaboration skills. Manage the creation and maintenance of compliance metrics, development of trend data of audit

/ inspection observations and communication of results expediently to applicable groups.

• Strong knowledge base in all aspects of quality including quality control, calibration, validation.

• Excellent management, business and leadership experience to guide the department to right path for best GXP/GDP/DI/ALCOA+ practices. Also, capable of resolving multiple issues simultaneously.

• Expert in final reviewing biopharmaceuticals Batch Records (MBR/EBR), finished products, in-process, stability and CoA.

• Expert in auditing, pre-audit, audit readiness experience to make sure compliance with GMP/GXP/GDP/Data Integrity/ALCOA+ and 21 CFR Part11 with FDA regulations and with other agencies. Brought great ideas to prevent and reduce major/critical observations and reduce number of deviations/Investigations.

• Critical technical skills, accurate, organized recording, lab safety, regulatory compliance, process improvement, and service delivery for increased efficiency. Experience in small and large molecules.

• Talented at multi-tasking, verbal and written communicating across departments.

• Using electronic systems: SAP, LIMS (Labvantage and Citrix), Trackwise, Veeva, DARA, and BlueMountain.

• Expert in training, coaching/mentoring new team members on new procedures. Also, collaborate with functional leads to ensure effective communication to resolve critical issues. Knowledgeable in Microsoft Office tools, Electronic Document Management Systems. Expert in ICH-GCP guidelines, CFR Title 21, Part 11, and delivering GxP.

• Biotechnology and Pharmaceuticals international experience.

• Experience with multiple electronic systems: Plateau, NuGenises, ISOtrain, with knowledge of API & ASTM, MSDS, OSHA, 5S & LEAN Sigma. Validation (IQ, OQ, PQ).

• Expert with pre-approval of investigation, deviation, Root Cause Analysis (RCA), CAPA, OOS, OOT, and LE.

• Over 30 years’ experience of EH&S and usage of PPE.

• Lead continuous improvement on targeted business processes, using Lean Sigma, to reduce deviations. Experience and Achievements:

Various Companies May-2024 to Jun2025

Sanofi / BMS: QA Manager (Complementary / Temporary Position)

• Reviewing deviations in VEEVA QMS as per GMP, GDP, Data Integrity and ALCOA+.

• Successfully done weekly quality metrics for: Stand Alone, Effectiveness Check, and Action / CAPAs.

• Reviewing Master Batch Records MBR/EBR.

• Bring the best for the team for Right First Time (RFT) Process Improvements and efficiency.

• Done Auditing and report observations.

Gsk vaccines, MA Jul-2023 to Feb-2024

Senior Investigator, Supply Chain / Manufacturing (Complementary / Temporary Position)

• Professionally reviewing Manufacturing Batch Records (MBRs) data reviewing and remediation to multiple issues and implemented training to manufacturing, Supply Chain and warehouse teams. Improved MBR personnel’s performance (Right First Time) by suggesting excellent training system, led by examples as per GDP/Data Integrity and ALCOA+.

• Conduct regular inspections and audits of production processes to identify quality issues and NCR's.

• Prepare and gather statistics, using statistical system DARA for quality council monthly senior management monthly meetings presentation.

• Investigate and analyze the Root cause and developed CAPA. Change control by revising SOPs to improve performance of whole department, and to reduce number of deviations.

• Reviewing Investigations & Deviations for supply chain dept., using SAP system and other systems (i.e., BioIT).

• Trained supply chain groups on GDP/GMP/Data Integrity/ALCOA+, by presenting many PowerPoint slides with live examples on how to do it Right First Time (RFT).

Eurofins Pharmaceutical Science / Consultant & Various Companies, MA Mar-2017 to Dec-2022 QA Specialist Compliance

• Project management and proficient with Deviations/Investigation/Trackwise/Veeva, QMS, RCA, CAPA, OOS, OOT, and LE. Also reviewed Batch Records (MBRs), Data Packages generated by different levels of analysts, Validation Protocols, column steps and peer review for accuracy and compliance. Reviewing experience of IQ, OQ and PQ documents. Also, remediate issues and developed plan to reduce number of deviations in QC/QA Dept.

• Worked on Veeva, Business Analyst responsibilities and gathering documentation and implementation eQMS.

• Worked with Contract Development Manufacturing Organizations (CDMO, Drug Development, …) for biopharmaceuticals products. For clinical and commercial products.

• Change control by revising SOPs to remediate as corrective actions to improve performance of whole department, and to reduce number of deviations.

• Apply problem solving skill to achieve a compliant resolution from R&D, MFG, Tech Service.

• Managed Quality team and directed them to best and top GDP/DI/ALCOA+ practices in GMP environment to investigate deviations in quality systems, and find solutions. Also trained the team on how fill gaps in quality systems by creating CAPA. Reviewing QC / QA data and LIRs. Experience with commercial stability samples.

• Brought the best ideas and solutions to quality system, to eliminate gaps and reduce the number of deviation and investigations drastically.

• Build effective network and communication with Plant Leadership Team, Quality and Regulatory functions, other plant Quality Managers and other key functions of Engineering, Supply Chain, etc. to ensure alignment around global and local priorities and in driving overall plant performance relying on a strong culture of Quality and Continuous Improvement.

• Lead continuous improvement on targeted business processes. Able to formulate a strategic approach for difficult complex issues.

• Independently perform issue analyze assessments and determine impact.

• Investigating OOS/OOT/QE using TrackWise/Veeva systems. Also root cause analysis (RCA), and deviations trending.

• Resolved direct reports issues and held meetings within departments and externally.

• Auditing experience and walkthrough to QC, Manufacturing, Warehouse and Packaging, to make sure compliance with GMP/GXP/GDP/Data Integrity/ALCOA+, as per FDA regulations. Also, to prepare for FDA, TGA, Health Canada and EMA Auditing/inspection.

• Provide leadership directions/objectives, coaching and personal development of Associates to perform to their best ability and meet both personal and plant objectives.

• Highly organized within the group and on multiple levels on daily activities.

• Able to communicate efficiently, internally and externally to get the job done to final stage on timely manner. Sanofi/Genzyme, MA Feb-2012 – Dec-2016

Senior QC Analytical Chemist

• Pre-Auditing preparation experience for FDA, Canadian and EMEA inspection.

• Professional review of QC data and LIRs. Proficient in testing Biopharmaceuticals: Finished Products, in-process and stability samples using: HPLC, U V spectrophotometer for PNP, Bradford & A280. Proficient using and testing Atomic Absorption Spectrometer (AA) samples for sodium and zinc.

• Investigation experience for OOS/OOT and capable of opening QE using TrackWise/Veeva systems. And finding the root cause analysis and doing CAPA for critical and major deviations.

• Verifying data packages, verifying test results in GMP & None GMP environment. Also, troubleshooting methods and HPLCs and other lab instruments.

• Perform QC data packages review for Drug Product / Drug Substance, and approval of documents before product release. Proficient using LIMS system.

• Tracking and trending of generated QC data to make sure analysis results within specification.

• Run Method Validation protocols on different analysis, to validate methods.

• Ability to analyze a problem/situation and recommend solutions.

• Tested samples and troubleshoot HPLC Chemstation/Empower, POROS/Concentration, SEC/Aggregation, etc. analysis for in- process stability and finished products, etc. for lyophilized/Injectables and biological products. Abbott Labs and Other Co. (QC Analytical Chemist / Research Associate). 2002-2009 HPLC, UV, SDS-PAGE, TOC, LIMS, Reviewing QC Data, Lab Auditing, Data Integrity, GDP, GMP. Education & Skills:

Toronto University Evaluation-D.U. Faculty of Science (Possess USA Equivalency) Bachelor of Science Degree (Four Years) Applied Chemistry.

Chemistry Lab Courses: HPLC, LC-MS, GC and Lab. Assay Methods. Computer courses: CBS: Microsoft Office. Toronto, ON. Sep-1998 Courses & Seminars:

Lead Auditor (ISO-19011:2018) 13Jun24 Lean Sigma Green Belt 02Mar24 ISO Management System Audit Techniques and Best Practices 28Feb24 Medical Devices, Quality Management Systems (ISO-13485 :2016) 24Feb24 Internal Auditor Certificate (ISO-9001 :2015) 05Sep21 Lead Auditor, Auditing Techniques for Clinical Research Professionals (Barnett International), Drug Safety and Pharmacovigilance, cGMP: Good Manufacturing Practice & GCP: ICH Good Clinical Practice (ICH-GCP). Project Management, Time Management skills, LC-MS Techniques, Interpretations & Instrumentation, Method & Instrument Validation, Ion Chromatography and few HPLC courses. GSK Short courses: EH&S, WHMIS, Network Exchange, Multichrom, Lean Sigma, Words L-2, Method & Instrument Validation (PSG), CVG seminars & GMP. Honors and Awards:

Received a Certificate Award for completing successfully five years contributing to success of launching active pharmaceutical ingredient, working in QC Labs.

Memberships: Member of American Society for Quality.

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