Quality Assurance Systems

John F. Weir

**** ***** **, ********* **, ***** *60. 470.9338 Email: mailto:**********@*****.***

SUMMARY

Experienced Quality Assurance Specialist with over 11 years in GMP-regulated environments, including biopharmaceuticals, vaccines, and biologics. Specializing in Quality Operations, batch disposition, and CDMO oversight, with a proven track record of ensuring compliance with FDA, EMA, and global regulatory standards. Expertise in drug substance (DS) manufacturing oversight, deviation management, CAPAs, and batch release. Adept at collaborating with external manufacturing partners (CDMOs), managing quality systems, and supporting regulatory submissions (CMC sections). Strong background in analytical method verification, stability program oversight, process validation, and EDMS administration and configuration. Experienced in drafting and reviewing Customer Notification Letters (CNLs) to communicate quality-related issues and ensure regulatory compliance. Committed to continuous improvement, risk-based decision-making, and maintaining audit readiness in fast-paced, high-stakes environments.

PROFESSIONAL EXPERIENCE

Quality Systems Senior Specialist

Moderna June 2024 – December 2024

Provided QA oversight for batch disposition of drug substance (DS) manufactured by CDMO partner, Rovi, ensuring compliance with GMP regulations and quality agreements.

Reviewed and approved CDMO batch records, analytical method SOPs, validation reports, and stability protocols, ensuring adherence to regulatory and internal quality standards.

Assessed and approved QC method qualification and stability studies, ensuring consistency and compliance with global requirements (FDA, EMA, ICH).

Monitored and reviewed deviations, CAPAs, and change controls related to CDMO manufacturing and testing activities, ensuring timely resolution and regulatory compliance.

Collaborated with cross-functional teams—including CDMO Quality, Manufacturing, QC, and Regulatory Affairs—to facilitate batch release and resolve quality issues.

Supported regulatory inspections and internal audits, maintaining GMP compliance and audit readiness for CDMO-related manufacturing operations.

Quality Systems Senior Specialist

Vertex Pharmaceuticals April 2023 – June 2024

Conducted batch disposition activities for cell and gene therapy operations

oReviews batch records, deviations, in-process data, Environmental Monitoring data, approval of QC release testing (endotoxin, mycoplasma, sterility, flow cytometry, karyology etc)

Lead site QMS (quality management system) weekly review meetings (CAPAs, deviations, change controls)

Reviewed and reconcile labeling operations for drug substance

Provided production floor support and guidance for GMP product quality and compliance for release

QA reviewed and approved of IQ/OQ/PQ activities for manufacturing equipment

Site EDMS/LIMS administrator participating in testing, validation, maintaining user accounts, and system administration, supporting hardware and software changes tracked by established change controls

Provided QA support of change controls, GMP investigations, CAPAs, OOS and OOT investigations to ensure appropriate CAPA activities are identified

Participated in inspection readiness and support activities, including drafting CNL notifications

Assisted in document control activities; controlled document issuance, review, and reconciliation.

Quality Assurance Analyst II/III

Emergent BioSolutions March 2020 – March 2023

Performed QA disposition of raw materials, reagents/reference standards and in-process intermediates

Reviewed GMP-compliant equipment validation, calibration, and maintenance documentation

Reviewed all building monitoring systems and events for Emergent San Diego Facilities

Drafted CNLs (Customer Notification Letters) to address potential product recalls, changes to specifications and stability concerns

Provided QA oversight of Validation of new equipment (CQV)

oFocus on reviewing documents: protocols, reports, SOPs and Forms

oReview and approval of IQ/OP/PQ results

Hosted/conducted monthly quality management systems review meetings

Conducted batch record reviews

Conducted GMP line clearance and product changeover reviews and approvals

Oversaw Supplier Initiated Change Request triage acknowledgement and distribution

Responsible for oversight of GMP equipment and facility building monitoring system reports

Oversaw new equipment impact assessments, investigations of deviations, quality incidents, and preventative maintenance

Responsible for issuing and reviewing GMP logbooks

Document Control Specialist

Pride Resource Partners December 2019 – February 2020

Provided Documentation oversight for reliability enhancement project

Tracked project documents in a SharePoint Database, provided training, assisted in record management procedures and policies including documentation, record retention and retrieval

Performed internal audits on project documents and database user accounts

Quality Assurance Associate/Technical Support Services June 2018 – July 2019

Abbott Laboratories

Worked cross-functionally to identify risk and evaluate deficiencies that potentially lead to nonconformance

Conducted post market surveillance, and sent CNL (Customer Notification Letters) to address product quality issues, field actions, and stability concerns

Evaluated internal controls and performed risk assessments to stay compliant with internal and external safety, quality, and regulatory standards

Identified compliance issues by monitoring for nonconformances based on the company’s established QA processes and standards for a GMP facility

Experience with ISO 9001 and ISO 13485 standards

Assisted in execution of CAPA and completed investigations to ensure accuracy and adequate documentation

Supported regulatory compliance activities for post market vigilance reporting

Assisted in consolidation, organization, and digitation of vendor certification documentation

Client Service Specialist June 2017 – November 2017

AltheaDx, San Diego, CA

Coordinated the receiving, inspection, verification, cataloging and barcoding of genomic samples utilizing an electronic material inventory management system

Responsible for the implementation of corrective actions to rectify missing patient information and result reports between laboratory and physicians

Conducted quality reviews of specimen documentation to ensure compliance with company’s procedures

Assisted with plate mapping, data entry, and document processing

Specimen Resolution Specialist OCT 2015 – MAY 2017

Millennium Health, San Diego, CA

Created and implemented SOPs on the rejection process for specimens

Trained existing and new employees on the specimen rejection process as well as the processing, storage, and inventory management of received specimens

Investigated, troubleshooted, and resolved compliance issues that arose during the processing of specimens

Laboratory Data Processor MAY 2015 – OCT 2015

Processed patient data in an organized and efficient manner using an EDMS

Verified patient insurance information and confirmed accuracy of existing data

EDUCATION

University of California, Irvine, Bachelor of Arts (B.A.) in History

Mira Costa College, Associates Degree in Chemistry

SKILLS

Microsoft Office (Word, Excel, PowerPoint)

MasterControl Quality Management System, SharePoint, Agile Product Management, Veeva Vault, TrackWise, ArcGIS, SolidWorks, Adobe, Paperport, Voloview, AutoCAD, LIMS, Oracle OPM, Aquila MES, SAP Odyssey

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