GMP Quality Manager - Batch Release & Compliance

Casey Hunter

*** *. **** *. **** ****, Rexburg, ID 83440

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

GMP QUALITY MANAGER PHARMACEUTICAL QUALITY BATCH RELEASE & DISPOSITION

GMP Quality professional with 15 years of progressive experience in pharmaceutical and medical device environments, including Quality leadership within FDA-regulated manufacturing. Extensive experience supporting and performing batch record review, product release and disposition, GMP compliance, investigations, CAPA, change control, risk management, supplier/CMO oversight, audits, and Quality System improvement. Experienced in evaluating technically complex Quality events, developing practical corrective actions, authoring and approving technical documentation, and partnering with Production, Supply Chain, Engineering, Regulatory, R&D, suppliers, and senior leadership. ASQ Certified Quality Auditor with Lean Six Sigma Green Belt training and strong experience improving GMP workflows and electronic Quality Systems.

CORE COMPETENCIES

GMP & Product Quality: cGMP 21 CFR Parts 210/211/11 Batch Record Review Master & Executed Batch Records Product Release & Disposition Drug Substance/Product Quality Release & Stability Documentation GMP Documentation Data Integrity

Quality Systems: Investigations CAPA Change Control Risk Management Deviations/Nonconformances SOPs & Procedures Document Control Training Audit/Inspection Readiness QMS Improvement eQMS Implementation & Validation (TrackWise, MasterControl, QCBD and others) ERP Systems (Oracle, SAP, JDE and others)

External Partners: CMO/Supplier Quality Contract Laboratory Coordination Supplier Qualification Supplier Audits Quality Agreements Supplier Corrective Actions Approved Supplier Lists Supplier Risk & Performance Cross-Functional Partner Management

Problem Solving & Leadership: Root Cause Analysis 5 Whys 5W2H 8D 6M/Fishbone pFMEA Risk Assessment KPI/Trend Analysis Power BI Technical Writing Cross-Functional Leadership Senior Stakeholder Communication

EXPERIENCE

QUALITY PLANT MANAGER Lubrizol 2023–2025

Led Quality for two FDA-registered manufacturing facilities, partnering with Operations, Engineering, R&D, Supply Chain, Facilities, Safety, suppliers, customers, and senior leadership to maintain compliant and reliable production.

Managed investigations, CAPAs, change controls, customer complaints, risk assessments, product quality issues, and corrective actions, including development of test plans to identify failure modes and sustainable solutions.

Managed contract laboratory testing for sterility and environmental monitoring plates.

Reviewed and approved manufacturing documentation, product specifications, drawings, quality records, and controlled procedures supporting product release and disposition activities.

Developed Power BI KPIs, dashboards, and trend reporting to identify recurring issues, monitor Quality performance, and prioritize improvement opportunities.

Updated the supplier Quality program, improving supplier qualification, tier-based supplier reviews / audits, Approved Supplier List management, Quality Agreements, contracts, SCARs, and supplier corrective actions.

Led multiple equipment, safety, process improvement, qualification, and validation projects while integrating Quality requirements into operational workflows.

Served as Management Representative hosting all customer and ISO audits and supported regulatory compliance, inspection readiness, and audit responses.

Developed and improved procedures and workflows using controlled documentation practices and emerging AI tools to increase process efficiency and consistency.

Managed and developed Quality personnel while providing GMP/GxP training and communicating Quality priorities to site leadership.

Managed and performed batch record reviews and product dispositions. Generated CoCs for acceptable product.

Led Material Review Board meetings for decisions on impacted material and product dispositions.

SUPPLIER QUALITY MANAGER StatLab 2022-2023

Managed supplier Quality processes supporting FDA-regulated manufacturing, including supplier qualification, audits, investigations, corrective actions, Quality Agreements, supplier notifications, and Approved Supplier List controls.

Created Power BI reports to track and trend supplier related issues and used risk-based analysis and Power BI reporting to prioritize supplier oversight and identify performance trends.

Partnered with Operations, Engineering, Supply Chain, and external suppliers to resolve complex Quality issues and maintain compliant supply.

QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER Compound Preferred 2020–2022

Led Quality and Regulatory activities for an FDA-registered 503B pharmaceutical outsourcing facility operating under 21 CFR Parts 210–211.

Audited testing laboratories to ISO 17025 standards, qualifying a new testing service provider and excluding another.

Worked with laboratories to develop test methods per USP requirements. Ordered and reviewed all environmental plate testing and finished product testing.

Managed and performed batch release/disposition, investigations, CAPA, change control, risk management, supplier Quality, audits, training, and GMP documentation.

Reviewed Quality and manufacturing documentation supporting product release and compliance.

Implemented a 21 CFR Part 11-compliant electronic QMS covering investigations, CAPA, change control, document control, training, supplier management, audits, risk management, and electronic forms.

Led requirements development, workflow design, URS testing, validation, implementation, procedures, and training for the eQMS.

Served as Quality lead during FDA regulatory activities, including response to FDA 483 observations and onsite inspection activities.

Developed technical documents and procedures and provided Quality guidance to cross-functional teams, vendors, consultants, and leadership.

Created Power BI reporting for Quality metrics, investigations, and compliance trends.

QUALITY ASSURANCE SENIOR SUPERVISOR Melaleuca 2019-2020

Led U.S. product complaint, nonconformance/deviation investigation, CAPA, and Quality event activities for an FDA-regulated pharmaceutical manufacturing environment.

Improved complaint and Quality event workflows and trained manufacturing personnel on investigations, CAPA, and process improvement.

Used MasterControl and Power BI to manage, analyze, trend, and report Quality events and identify recurring issues.

Supported GMP Quality System improvements and validation of MasterControl system updates.

QUALITY ENGINEER Teva Pharmaceuticals 2012-2018

Supported pharmaceutical manufacturing under 21 CFR Parts 210–211, including GMP documentation review, in-process testing/inspection, raw material disposition, deviations/nonconformances, CAPA, and Quality System audits.

Performed product disposition activities using Oracle, including review of product information and manufacturing requirements; supported BOM creation and maintenance.

Participated in external audits and FDA/customer inspections and supported gap assessments and Quality System improvements.

Participated in TrackWise Global implementation, including requirements/URS testing and validation activities.

Performed investigations of raw materials, intermediate products, finished products, processes and lab test results, and implemented CAPAs and Effectiveness checks.

EDUCATION & CERTIFICATIONS

Bachelor's Degree – Idaho State University

ASQ Certified Quality Auditor (CQA)

Lean Six Sigma Green Belt Training – University of Utah

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