Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
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Benjamin Boateng

Shrewsbury,ME

Summary

Quality Assurance and Compliance Specialist with over 7 years of experience in GMP biomanufacturing and pharmaceutical operations, committed to maintaining the highest standards of quality. Expertise includes batch record review, deviation investigations, CAPA management, and audit readiness, ensuring compliance with regulatory requirements. Certified in Six Sigma Green Belt, fundamentals of Biomanufacturing, and Industrial Biotechnology, consistently driving initiatives that enhance compliance, operational efficiency, and continuous improvement within regulated environments. A proactive problem-solving approach and keen attention to detail contribute to successful outcomes in complex projects.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Quality Assurance Specialist

Moderna
04.2025 - 08.2025
  • Performed real-time batch record reviews for media and buffer prep, reducing review cycle time by 20%.
  • Led AQL inspections and quality checks, ensuring compliance with internal and FDA standards.
  • Investigated deviations, collaborated cross-functionally, and drove CAPAs to prevent recurrence.
  • Authored and revised SOPs and GMP documentation, strengthening audit readiness.
  • Authorized equipment release/tag outs, ensuring uninterrupted manufacturing operations.

Technical Specialist

Moderna
03.2023 - 03.2025
  • Supported batch record documentation review and managed eBR/MBR disposition in SAP.
  • Led deviation investigations, root cause analysis, and CAPA implementation to address recurring issues.
  • Partnered with cross-functional teams to drive process improvements and enhance audit readiness.
  • Prepared technical reports and ensured compliance with regulatory standards.
  • Led cross-functional teams to enhance product development processes and improve operational efficiency.

Manufacturing Compliance Engineer II

Sanofi
05.2022 - 04.2023
  • Directed deviation investigations and implemented CAPAs, reducing deviation recurrence rates.
  • Revised and maintained over 200 batch records and manufacturing procedures monthly to align with GMP.
  • Delivered on-the-floor training and mentored new investigators.
  • Spearheaded cross-functional continuous improvement projects.
  • Enhanced documentation and reporting through Smartsheet and Microsoft Office.

Manufacturing Associate II

Repligen Corporation
10.2021 - 05.2022
  • Supported GMP compliance with accurate batch record documentation and deviation reporting.
  • Completed ISO9001 QMS documentation and assisted with process optimization projects.
  • Handled column packing, storage, and neutralization processes.
  • Implemented standard operating procedures to enhance consistency in manufacturing operations.
  • Exceeded daily production targets with consistent attention to detail and commitment to meeting deadlines.

Manufacturing Technician II

AbbVie
01.2019 - 10.2021
  • Performed cGMP manufacturing operations including buffer/media prep and chromatography.
  • Operated LIMS, SAP, and automated control systems for production tracking.
  • Executed CIP/SIP and autoclave operations for equipment preparation.
  • Conducted cell culture operations from vial thaw to production scale.
  • Spearheaded initiatives for continuous improvement, driving operational excellence within the manufacturing team.

Machine Operator

Nypro (A Jabil Company)
01.2018 - 01.2019
  • Operated and maintained manufacturing equipment, ensuring production efficiency.
  • Trained junior operators and conducted routine equipment inspections.
  • Operated machinery to ensure production lines functioned efficiently and met quality standards.
  • Monitored equipment performance, promptly addressing issues to minimize downtime and enhance productivity.
  • Implemented process improvements that increased workflow efficiency and reduced waste in production processes.

Program Manager

Devereux Advanced Behavioral Health
05.2015 - 01.2018
  • Supervised and supported individuals with developmental disabilities.
  • Developed care plans and facilitated personal development strategies.
  • Facilitated stakeholder meetings to align project goals with organizational objectives and client needs.
  • Managed resource allocation effectively to optimize project timelines and deliverables across multiple programs.
  • Developed comprehensive training programs for staff, improving service delivery and client satisfaction rates.

Education

B.A. - Business Administration & Management (Insurance)

University of Ghana Legon
Accra, Ghana
03.2015

Associate of Science - Business Administration And Management

Mount Wachusett Community College
Gardner, MA

Skills

  • Quality & Compliance: GMP, SOPs, Batch Record Review, Deviation Management, CAPA, Auditing
  • Process Improvement: Lean Six Sigma, Continuous Improvement, Root Cause Analysis
  • Technical Systems: SAP, LIMS, eBR/MBR Systems, Smartsheet, Microsoft Office
  • Collaboration & Leadership: Training, Cross-Functional Teams, Documentation Control

Websites

Certification

  • Six Sigma Green Belt
  • Fundamentals of Biomanufacturing & Industrial Biotechnology
  • CompTIA Security+
  • Six Sigma Principles

Timeline

Quality Assurance Specialist

Moderna
04.2025 - 08.2025

Technical Specialist

Moderna
03.2023 - 03.2025

Manufacturing Compliance Engineer II

Sanofi
05.2022 - 04.2023

Manufacturing Associate II

Repligen Corporation
10.2021 - 05.2022

Manufacturing Technician II

AbbVie
01.2019 - 10.2021

Machine Operator

Nypro (A Jabil Company)
01.2018 - 01.2019

Program Manager

Devereux Advanced Behavioral Health
05.2015 - 01.2018

B.A. - Business Administration & Management (Insurance)

University of Ghana Legon

Associate of Science - Business Administration And Management

Mount Wachusett Community College

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