Pharma QA Auditor and Data Integrity Expert

BRIAN GLAZER

****PAVAROTTI TERR. BOYNTON BEACH, FL 33437 ************@*****.***

SUMMARY

Quality Assurance Specialist with over 40 years in pharmaceutical and biotech industries, including 10+ years of method validation, equipment qualification and data integrity program support. Expertise as Waters Empower™ and Agilent OpenLAB™ system admin- istrator ensures compliance with 21 CFR Part 11, FDA and GMP requirements. Proven leader in coaching GMP principles, conducting audits, and managing CAPAs and change controls. Skilled in training cross-functional teams on data integrity and regulatory best practices.

SKILLS

•Quality & Regulatory Compliance: CGMP Experience, GMP Principles, 21 CFR Part 11 Knowledge

•Data Integrity: Data Integrity Projects

•Software & Systems: Microsoft Excel, Waters Empower, Agilent Technologies OpenLAB ChemStation/ChemStore, System Admin- istration

•Analytical Techniques: Analytical Skills, HPLC, UPLC, GC, MS, ELSD, CAD, Anderson Cascading Impactor (ACI), NGI, UV/Vis Spectrophotometer, SEC, FTIR, iCE, CGE, Peptide Mapping, Residual DNA, Host Cell Protein (HCP), qPCR, Durometer, Disso- lution, DSC, Environmental Monitoring (viable and non-viable), Atomic Absorption, Flame Emission, Liquid Scintillation Counter, Melt Index Extruder Rheometry, TOC Analyzer, Particle Size Determination, Potentiometric Titrations, Karl Fischer, Wet Chemistry, Microbiological Endotoxin, Sterility, Pyrogen testing

•Leadership & Training: Leadership, Supervision, Training

EXPERIENCE

FUJIFILM BIOTECHNOLOGIES

Sep 2024 - Sep 2025

Quality Assurance Auditor

College Station, TX

•Responsible for the review and/or approval of basic and technical documentation, i.e., method transfers, ensuring compliance with 21

CFR Part 11.

•Reviewed and approved DP, DS, BDS for release and stability testing using strong analytical skills. Reviewed testing included Identity,

Color/Clarity, Particulates, pH, Osmolality, Protein Concentration, Imaged Capillary Iso-Electric Focusing (icIEF), Reduced/non-re-

duced capillary electrophoresis, Size Exclusion Chromatography (SEC), Glycans Profile, Endotoxin and Bioburden.

•Drafted and reviewed internal quality policies and procedures incorporating GMP principles.

•Assisted in and performed QC laboratory inspections for remediation, agency readiness, and data integrity projects.

•Performed validation review utilizing real time Polymerase Chain Reaction (rt-PCR).

•Wrote and reviewed Laboratory Deviations/OOS investigations.

•Utilized Veeva Vault and Compliance Wire for GMP document storage, drawing on CGMP experience.

TAKEDA BIOLOGICS

May 2023 - Jun 2024

Quality Control Technical Writer

•Wrote microbiological method validation reports and protocols.

•Wrote, revised, and collaborated on Standard Operating Procedures.

•Utilized Veeva Systems and Microsoft Excel for company-wide documentation and data analysis.

•Worked with Change Controls and CAPAs.

Lexington, MA

AGC BIOLOGICS Jun 2022 - Mar 2023

QC Chemist Bothell, WA

•Performed QC analysis and documented activities according to SOPs following good manufacturing processes (GMP) and demon- strated ability to learn QC methods, procedures, and systems.

•Performed reintegration for chromatography-based methods.

•Wrote, revised, and collaborated on technical documents such as SOPs, analytical methods, and method attachments.

•Wrote quality events, deviations, CAPAs, and change requests and performs investigations to support quality management systems.

•Used a combination of HPLC, UPLC, CE and iCE3 instrumentation to support laboratory testing.

SEQENS Jun 2021 - Jun 2022

Senior Q.A. Data Reviewer Newburyport, MA

•Responsible for performing quality data reviews.

•Review of analytical records generated during testing of API and drug product for compliance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Records include, but are not limited to lot release, stability, and raw material test records.

•Review/approval of method validation protocol, data and report.

•Review and approve GMP quality control test records per approved procedures.

•Ensure compliance to good documentation practices and verify calculations, appropriate test method/specifications applied for sample testing.

•Review of analytical data for accuracy, completeness, and FDA compliance. Data includes lab notebooks, logbooks, chromatography, and electronic data/audit trails.

•Provide review and input for QC/analytical SOPs, test methods, protocols and technical reports.

•Provide support and oversight for resolution of deviations and non-conformances related to Quality Control activities, including investigation of Out of Specification results and ensure proper corrective and preventive actions (CAPA) are taken.

•Provide review and input for generation of new or revised QA SOPs and other controlled documentation. Author quality documents as assigned.

EMERGENT BIOSCIENCES INC. Oct 2019 - Dec 2020

Validation Specialist Baltimore, MD

Responsible for leading the Quality Control validation commitments to support an upcoming pre-approval inspection.

•Wrote protocols and reports for validation of a monoclonal antibody.

•Methods employed analytical equipment including HPLC/ELSD, PDA and qPCR detection.

•Reviewed, revised and approved SOPs and test methods.

•Updated stability records and prepared reports and tables, for annual product review.

•Filled in for departmental management at planning and quality functions.

AKORN, INC. Apr 2019 - Jul 2019

Technical Writer Somerset, NJ

Responsible for supporting the Quality Control group on the integration, operation and completeness of Method Validation reports for the corporate Quality Management Systems.

•Performed method validation gap assessment against regulatory requirements including ICH, USP monograph and other FDA requirements.

•Reviewed historical quality data for method performance.

•Evaluated method performance via review of recent analyses.

•Conducted interview to discuss method performance with internal QC chemist, supervisors and data reviewers; and external data reviewers and consultants to determine any known method information.

•Provided assessment report for each method evaluated, along with recommendation for any required method remediation activities.

NOVO NORDISK U.S. BIOPHARMACEUTICALS Oct 2017 - Sep 2018

QC Specialist W. Lebanon, NH

Responsible for supporting the Quality Control group on the integration of corporate Quality Management Systems in anticipation of an FDA Pre-Approval Inspection.

Revised existing quality documents such as SOPs, Work Instructions, validation protocols and other documents.

Wrote IQ/OQ/PQ for equipment qualifications.

Performed gap assessments.

Created job training as defined by the project plans.

Responsible for timeline planning coordination both within the QC team and the Documentation Group.

Reviewed CAPAs for completeness and closure.

PATHEON BIOLOGICS Jul 2016 - Oct 2017

Technical Writer- SME St. Louis, MO

•Authored method validation and reports, and equipment protocols (IQ/OQ/PQ).

•Demonstrate the ability to perform and train analysts on method validation and method transfer protocols.

•Wrote test methods for various bioassays and biological analytical techniques. Analytical techniques included ELISA, iCE, CGE, Western Blot, Residual DNA, Host Cell Protein, SEC, Peptide Mapping, Mannose-6-Phosphate and Sialic Acid residual determinations.

ABBOTT DIAGNOSTIC DIVISION Aug 2015 - Jul 2016

Professional Quality Irving, TX

•In-depth understanding of diagnostic products, processes and technologies.

•Understand multiple technologies and instrument platforms to support multiple products and projects.

•Utilize statistical tools to analyze data.

•Understand quality control procedures and manufacturing processes for final product.

•In-depth understanding of change controls and can assess its justifications.

•Ability to identify issues, assess risk, make recommendations and elevate issues as required.

•Knowledge of clinical applications for products for which they are responsible.

•Understands intended use and off-label uses of products.

•Responsible for implementing and maintaining the effectiveness of the quality system.

•Participates a new product team member and is able to identify and elevate critical issues.

•Trains others and troubleshoots problems.

•Prepares and aligns departmental goals with business goals.

•Participates and may lead and cross-functional teams.

•Occasionally interact with federal agency representatives and other external customers.

•Applies problem-solving skills to wide variety of problems: manufacturing process, failure investigation; product specifications and product design.

BIOTEST PHARMACEUTICAL COMPANY INC. Apr 2015 - Aug 2015

Validations Technical Writer (S.M.E) Boca Raton, FL

The FDA required remediation to company's quality systems and validation processes. Worked remotely and at client's pharmaceutical/bio- logical company site.

•Acted as a Technical Writer and worked with the validation and quality teams authoring protocols, change controls, technical documents, etc.

•Responsible for working with each team and provided best practices in terms of proper technical writing techniques.

•In-depth writing of system SOPs that included: Master Validation Plans, Analytical Master Validation SOP, Internal Method Transfer SOP, External Method Transfer SOP, Method Comparability SOP, Master Training SOP, Master Equipment Qualification SOP, Microbiological Validation SOP.

•Required understanding of cGMP environment and regulatory requirements for the development, validation of analytical and micro- biological methodologies, comparability and transfer of analytical methods.

PROCTER & GAMBLE COMPANY/TEVA PHARMACEUTICALS

Validations Scientist

•Performed IOPQ for Arizona Instruments Computrac® Moisture Analyzers (Model XL2000 & XL5000.

Jun 2014 - Apr 2015

Phoenix, AZ

•Wrote validation protocol and report for Nitrogen, NF/EP assay, oxygen impurity, presence of carbon monoxide, and identification tests.

•Wrote USP/NF compendial verification protocol and report for USP monograph Arsenic <211> in gelatin capsules, caramel and calcium carbonate.

•Developed cleaning validation protocol for presence of aspartame after cleaning manufacturing vessels previously containing artificial sweetener to Sucrose based products.

•Write, review and revise department applicable SOPs.

•Process change controls and performs validation non-conformance investigations associated with qualification activities.

CARDINAL HEALTH INC. Nov 2013 - May 2014

Validations Engineer Phoenix, AZ

•Performed IOPQ for Agilent 6890A and OpenLAB ChemStation data acquisition software.

•In the Positron Emission Tomography (PET) division plan, manage, and execute the start-up, commissioning, and validation of new equipment and Software, assist in the creation of company cleaning and process validation master plans.

•Analyze validation test data to determine whether systems or processes have met validation criteria and are completed in compliance with FDA, cGMP, GLP, 21 CFR Parts 210 and 212 and all other regulatory standards.

•Identify deviations from established product or process standards and provide recommendations for resolving deviations.

•Authored, maintained, reviewed and trained validation protocols for Agilent OpenLAB ChemStation Chromatography Data Systems, Agilent 6890 Gas Chromatograph, Agilent OpenLAB ChemStation data acquisition software, Thermo Scientific Chromeleon® data acquisition software, and radiopharmaceutical production equipment. Certified OpenLAB ChemStation CDS administrator.

•Write, review and update validation protocols and reports; adjusted equipment or processes that required improvement.

•Other duties include preventative maintenance, maintenance of testing equipment and overseeing the inventory of laboratory and validation supplies.

NOVARTIS, INC. Apr 2012 - Jun 2013

Laboratory Controls SME/Regulatory Affairs Consultant Lincoln, NE

•Provided Comprehensive Product Assessment and Trending Reports for over-the-counter (OTC), generic and branded name products as part of a response to the FDA Consent Decree.

•Reviewed and providing assessments for Assays (Dissolution, Assay and Stability Indication Assays), method validation protocols and reports, product's specifications, instrument validation, change control review, stability program as part of Annual Product Review filing.

•Ensure methodology and procedures are compliant with current standards, compendiums and proposed revisions.

•Wrote validation protocols for the many and various equipment employed in the Quality Control Laboratory.

•Reviewed the disposition of laboratory (planned and unplanned) deviations, investigation reports (Out of Specification, Out of Trend, Corrective Action and Preventative Action) ensuring all deviations are thoroughly investigated, documented and proper corrective and preventative action is taken.

•Trained in TrackWise™ and SharePoint™ (electronic document repositories).

INTEGRA LIFE SCIENCES Jan 2012 - Mar 2012

Laboratory Manager: Chemistry and Microbiology Plainsboro, NJ

As Laboratory Manager of the group, defined, directed, coordinated and evaluated the activities of 14 associates in the Microbiology and Analytical Testing Labs, including developing, implementing and monitoring of policies and procedures that ensured the development, manufacture and distribution of medical products in compliance with applicable corporate, local, state, federal and international regulations, policies and procedures.

•Addressed warning letter observations.

•Responsible for initiating and documenting nonconformance reports, out of specification investigations, corrective and preventative actions, root cause investigations and other technical reports/investigations.

•Provided technical leadership and support to management for all microbiological and analytical programs, product development and customer-initiated projects.

•Oversaw the testing and data review for all-microbiological and analytical testing to ensure accurate, reliable data, timely reporting and preparation of all pertinent Microbiology and Analytical Testing reports.

•Managed the facility environmental monitoring program, including trending.

•Ensured that all projects and testing are consistent with GLP, QSR (including Design Control) 21CFR Part 820, ISO requirements for quality, as well as other requirements such as USP and AAMI.

INSMED INC. (formerly Transave Inc.)

Mar 2008 - Sep 2011

QC Manager: Analytical Research & Development/Metrology Monmouth Junction, NJ

Successfully managed a 6-person scientific team advancing an inhalation bio-therapeutic drug from Phase 2 to Phase 3 Clinical trials.

•Responsible for the day-to-day operations of the QC lab which included overseeing the testing and data review of all raw materials, components, in-process intermediates and finished products to ensure accurate, reliable data and timely reporting.

•Certified Water Empower™ User and Administrator.

•Managed laboratory resources to support QC operations including equipment, processes and supplies, maintenance and calibration.

•Schedule resources to maintain corporate timelines and maintained fiscal responsibility and budget compliance.

•Managed product and raw material stability program. Authored laboratory reports for stability and other studies.

•Led the investigation to determine the assignable cause of laboratory investigations (OOS & CAPA).

•Responsible for all outside contract laboratory testing. Participate in all internal and external regulatory inspections.

•Responsible for assisting in analytical research including method development/validation. Evaluate and improve existing methods and procedures. Develop, write and train new and improved SOPs, instrument methods and analytical testing procedures.

•Trained new employees in cGMP compliance. Prepare performance reviews. Interview and recommend potential candidates for laboratory employment as needed.

•Developed and oversaw company Master Calibration Plan. Evaluated and trouble-shoot metrology issues. Assisted in the evaluation, selection of external vendors who perform instrument maintenance and calibration/qualification. Schedule the maintenance and calibration of company equipment with the appropriate department Manager to minimize impact to laboratory operations while maintaining compliance. Reviewed all equipment qualifications and logbooks to ensure proper entries are accurate as required.

•Coordinated proper disposal of company waste and manage compressed gas orders.

ACCUMED INC. Dec 2006 - Feb 2008

Senior Quality Manager Lawrenceville, NJ

QC Laboratory department head directing a staff of one manager, 3 supervisors, 20 staff chemists, 2 technicians and 2 microbiologists.

•Responsible for review and approval of all raw materials, finished products, packaging components and microbiology for a private label generic pharmaceutical solid and liquid dosage manufacturer.

•Planned, coordinated and directed programs for research, product development, validation and improvement of manufacturing processes.

•Directed the operations of the quality department to include developing and maintaining SOPs, test methods, specifications and in-process analyses.

•Reviewed and conducted audits of cGMP processes and addressed deviation investigations.

•Approved modifications of formulas, standards, specifications and processes.

•Monitored stability program and authored annual product reviews.

•Designed company calibration program ensuring equipment integrity and compliance.

•Reviewed and improved enzyme assay procedure.

•Responsible for developing annual budget. Recommend and purchased capital assets to improve efficiency.

•Reduced microbiology turn-around time by implementing rapid microbiological determination equipment. Troubleshoot and maintain current equipment.

•Worked closely with the Graphics department to design and approve all printed components.

•Responsible for regulatory compliance governing labeling requirements.

•Project coordinator facilitating the development of the company's chemical hygiene plan and hazardous waste program management. Emergency action coordinator responsible for all aspects of facility safety.

STRIDES INC. Dec 2005 - Dec 2006

Quality Control Manager Somerset, NJ

Managed the Chemical, Instrumental and Microbiology departments to test raw materials, finished products and method develop- ment/validation for a soft gelatin pharmaceutical company. Handled the daily assignments for 8 chemists and 2 microbiologists.

•Reviewed and released all submitted samples. Prepared and documented change controls, out of specifications, laboratory investigations and SOPs in a timely and efficient manner.

•Provided employees with the tools and knowledge necessary to accomplish their goals and the company's goals.

•Selected, interviewed and trained new department members.

•Supervised the development and validation of all product release parameters and methodologies.

•Coordinated contract laboratory submissions and reports.

BARR RESEARCH Apr 2000 - Nov 2005

Technical Group Leader: Analytical Services Plainsboro, NJ

Managed 4-8-member professional laboratory staff including daily work assignments and compliance with current GMP. Directed daily laboratory operation, provided rapid response to internal customer needs.

•Scheduled analytical testing and provided technical services to assure project deadlines are maintained.

•Conducted performance appraisals and coached for professional improvement and career development.

•Responsible for analyses performed by contract laboratories, departmental budget, and advising management on analytical strategies.

•Managed the performance of analytical procedures and stability program supporting clinical trials and research product development for Investigation New Drug (IND) and New Drug Applications (NDA). Knowledgeable in ICH guidelines. Co-authored Chemistry, Manufacturing and Controls section of IND submission.

•An active member of the Company's overall Operation (OC) and Product Development Committees (PDC).

•Certified ChemStation/ChemStoreTM (Agilent Technologies) data acquisition administrator. As a Blue Mountain Certified Calibration Manager, employed validated software to manage calibration, maintenance and validation programs for laboratory equipment and instrumentation. Responsible for site metrology, calibration and troubleshooting of laboratory equipment.

•Certified Waters Empower data acquisition software (user) administrator. Member of corporate metrology team. Identified, evaluated, specified, and recommended the acquisition of new analytical instrumentation and software.

•Wrote reviewed and implemented SOPs required for compliant, safe and efficient department operation.

•Participated in writing chemical specifications, experimental test protocols, and regulatory submissions involving laboratory testing.

•Managed the auditing of laboratory reports, review of laboratory notebooks and data and completion of analytical investigations.

•Managed stability program to provide accurate and timely reporting of data regarding products, components and drug substances.

•Accountable for aspects of contract laboratories for analytical, microbiological, and cytotoxicological services.

•Audited for technical capability, managed the business relationship, and reviewed all work for scientific validity and compliance.

•Trained the analytical staff in scientific theory and skills and in the implementation of new or revised methods, procedures, and instrument operations.

•Maintained up to date knowledge of FDA and international regulatory requirements regarding the analytical and microbiological testing and support of clinical drug products.

•Remained active in professional organizations to enhance Division's knowledge of current industry practice.

•Active member of the Safety Committee serving as the Emergency Action Coordinator and Chemical Hygiene Officer for five years.

•Addressed all EPA, NJDEP and OSHA audits. Responsible for the proper handling and disposal of Hazardous Waste. Recommended safety procedures and policies to ensure compliance with Federal, State and Municipal regulations.

EDUCATION

UNIVERSITY OF ARIZONA, Tucson, AZ

BS, Pharmaceutical Chemistry

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