Summary
Overview
Work History
Education
Skills
Websites
Languages
Timeline
Generic

Rhonda Koska

Sturbridge,MA

Summary

Dynamic professional with over 20 years of experience navigating global industry regulations and best practices, including Data Integrity and FDA compliance. I have a deep understanding of the Drug Development and Pharmaceutical industries. Skilled in analyzing data and trends, using advanced I am skilled in Excel functions and multivariate statistics in JMP software. As an LMS Administrator for Success Factors, I managed training programs effectively. I pride myself on my strong communication skills, both written and verbal. I am a natural leader with problem solving and analytical thinking, and I am adaptable and flexible.

Overview

21
21
years of professional experience

Work History

Training Specialist

Moderna
03.2025 - 09.2025
  • oCOversee the management of cGMP personnel qualification documents and training files in the electronic document management system
  • Collaborate with SMEs to perform Training Impact Assessments and execute the related curricula and assignment changes
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
  • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
  • Complete training in assigned required learning plan according to the defined timing and the prescribed re-qualification cadence
  • Additional duties as may be assigned from time to time
  • Assisted in analyzing and assessing training and development needs for organizations, departments and individuals.
  • Documented participation and evaluated learning for each participant.
  • Completed over 1600 Service Now tickets.

Senior Compliance and Training Specialist

Sanofi
05.2020 - 11.2024
  • Managed iLearn LMS administration and developed training curricula, reports, and assessments for 74 people
  • Coordinated training for Drug Substance Manufacturing- Biologics (DSMB), Engineering (ENG),Validation and Clinical Injectable Manufacturing (CIM) staff, tracking progress and outcomes
  • Conducted cGMP document reviews and maintained compliance with Sanofi Standards
  • Led and participated in each quarterly facility Walk-through and maintained all work orders for walk-through findings
  • Reviewed all cleaning logbooks on a daily basis for area clearance
  • Reviewed ~100 equipment logbooks on a weekly basis in the manufacturing clean room
  • Participated in ~10 internal audits on a yearly basis and provided training information to the auditors
  • Worked on CAPAs, investigations and deviations in the compliance group
  • Created/revised/Obsoleted Standard Operating Proceeds using Veeva eDMS
  • Tracked documents in eDMS (Veeva) to maintain process flow
  • Assigned eDMS training to end users based on their role(s)
  • Created training materials and sessions to ensure trainers' readiness and consistency in learning standards
  • Created/Modified/Obsoleted Training Curricula and Groups within iLearn
  • Ensured quality compliance for all teams, acting as a key liaison with Quality Assurance
  • Performed archiving for all DSMB groups using Arpege
  • Tracked deviation and CAPA progress for the CIM group using Veeva Vault
  • Monitored and tracked all document revisions for the DSMB, Validation, Engineering and CIM groups
  • Created job aids to train compliance personnel

Training and Compliance Specialist

Sanofi
01.2017 - 05.2020
  • Managed Sanofi Training Systems to ensure cGMP compliance and high competence across DSMB, CIM, and ENG teams.
  • Served as the Training System expert, offering daily support and technical guidance.
  • Developed and tracked training programs for Clinical Trial Manufacturing, on-boarding, off-boarding, and SOP updates
  • Organized and maintained training records in eLMS, overseeing content updates and progress tracking
  • Collaborated on safety training and compliance audits, aligning with Document Control on procedure updates
  • Enhanced training systems to ensure compliance and regulatory standards

Senior Stability Specialist

Sanofi-Genzyme
01.2010 - 01.2017
  • Collaborated with cross-functional teams to resolve stability issues and ensure regulatory compliance
  • Represented Stability in meetings with Analytical SubTeam Leaders, CMC, and Regulatory Affairs for program alignment
  • Developed stability testing protocols for products using R&D Stability Documentation for Biologics Development
  • Ensured data compliance with FDA and cGMP requirements for IND submissions
  • Conducted stability data reviews and statistical analyses, supporting clinical trials and reporting
  • Maintained accurate inventory records and supported FDA and regulatory inspections
  • Trained staff on stability procedures and generated reports to drive process improvements
  • Create/Complete Change Controls

Stability Specialist

Genzyme
05.2009 - 01.2010
  • Monitored stability program for upcoming sample testing, managed testing schedules and disposition of material in support of testing, and ensured results were delivered from the testing labs
  • Supported data review of all programs
  • Maintained completed stability data tables and assesses data trending utilizing JMP statistical software.
  • Authored/reviewed internal stability protocols
  • Supported regulatory filing with stability data tables and trending, as needed
  • Wrote and/or revised SOPs and reports
  • Supported QC investigations, OOS, deviations, and CAPA implementation

Stability & Materials Manager

Avatar Pharmaceutical Services
09.2004 - 05.2009
  • Managed the cGMP Stability Study Program, ensuring compliance and accuracy
  • Collaborated with clients to complete Stability Documents and assisted in writing protocols
  • Trained personnel on Stability Study procedures and coordinated off-site testing for samples
  • Monitored stability graphs and reports, ensuring environmental chambers operated within specifications
  • Oversaw environmental logbooks and coordinated maintenance and repairs with vendors
  • Maintained all licenses, permits, and registrations for the facility
  • Conducted generator and pest management inspections to ensure operational integrity
  • Supervised the Materials Management & Shipping Department

Education

MasterTrack Certificate - Instructional Design

University of Illinois At Urbana-Champaign
Champaign, IL
05.2025

MBA - Quantitative Analysis

Southern New Hampshire University
Manchester, NH
05.2016

BS - Food Science and Technology, Biology, Mathematics

Framingham State University
Framingham, MA
05.1996

Skills

  • CGMP manufacturing
  • Data integrity
  • CGMP Stability Studies
  • Learning Management Systems
  • Compliance auditing
  • CAPAs, Deviations, Investigations
  • Change Controls
  • Create/revise/obsolete SOPs
  • Instructional Design
  • Training Impact Assessments
  • ADDIE Model
  • Veeva Vault
  • iLearn LMS
  • JMP Statistical software
  • Microsoft Office 365
  • Arpege
  • Phenix
  • Veeva eDMS
  • Success Factors (LMS)
  • Adobe Express
  • eLearning
  • Service Now

Websites

Languages

English
Native or Bilingual

Timeline

Training Specialist

Moderna
03.2025 - 09.2025

Senior Compliance and Training Specialist

Sanofi
05.2020 - 11.2024

Training and Compliance Specialist

Sanofi
01.2017 - 05.2020

Senior Stability Specialist

Sanofi-Genzyme
01.2010 - 01.2017

Stability Specialist

Genzyme
05.2009 - 01.2010

Stability & Materials Manager

Avatar Pharmaceutical Services
09.2004 - 05.2009

MBA - Quantitative Analysis

Southern New Hampshire University

BS - Food Science and Technology, Biology, Mathematics

Framingham State University

MasterTrack Certificate - Instructional Design

University of Illinois At Urbana-Champaign

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