Kathryn Granus
Quality Porfessional
Bowling Green,KY
Summary
Proficient Training supervisor with 14 years of experience. Excellent understanding of how to plan, lead and evaluate courses for new and existing employees. Trained in multiple Software platforms and extensive FDA, Food Safety, CFR, ISO and OSHA knowledge.
Overview
14
14
years of professional experience
Work History
Training Supervisor
Ball Corporation
05.2021 - Current
- Development of consistent and compliant training program for all stakeholders at start up manufacturing facility
- Lead training efforts to support on-boarding, technical and operational technical training program in alignment with industry guidelines and regulations
- Management of training status of employees, continual training and training matrix
- Continuous Improvement of site training programs and processes
- Development and deployment of specific technical training materials with the support of site SME’s
- Development of site WI and SOP’s
- Establishing a workflow process for document evaluation and revision process
- Facilitation and organization of continual training and outside vendor training
- ISO, FSSC 22000, ASI, Lean- Six Sigma , RCA, Document Control, 5S and Preventative Maintenance
- Management of site wide learning curriculums and records for 177 employees within the LMS.
- Enhanced employee performance by developing comprehensive training programs tailored to individual needs.
Senior Technical Training Specialist QA
Mylan
07.2020 - 05.2021
- Develop and provide training to stakeholder groups
- Maintained a 95% + on time learning completion for stakeholder groups
- Assist in enhancements to manage and deliver Train the Trainer Program
- Develop, implement and facilitate refresher cGMP training on an annual basis to GMP impacted employees and provide continual cGMP training throughout the year via instructor – led training, Computer Based Training, newsletters, posters, etc
- To 1800 employees
- Provide training support to stakeholder groups; end- user troubleshooting, assignments, content/curriculum development and curriculum management
- Learning Management System Administrator; managing training events in the LMS, and curricula for stakeholder groups (19 groups and 1800 site-wide)
- ELearning courses
- Documents of Standard Operating Procedures (SOPs)
- Virtual Live Training
- Questionnaire Surveys
- Task Checklists
- Registration and Tracking
- Instructor- Led courses
- Conferences
- Other External Events
- Blended Learning
- Curricula
- Programs
- Manage document masters, repository file structure and contents.
Senior Specialist Change Control NA Quality
Mylan Pharmaceuticals
05.2018 - 06.2020
- High Level evaluations of changes to registered documents for Third Party and Affiliate Sites
- High Level evaluations of Third Party and Affiliate Investigations and CAPA’s
- Monitor Third Party and Affiliate Investigations through Trackwise Workflow
- Strong understanding of processes, guidelines, and regulations of analytical and manufacturing data
- Initiate, administer, and track third party change controls
- Tracking and review of change control throughout TrackWise Workflow
- Monitor compendial updates and communicate updates to third parties
- Communicate daily with third parties, affiliate sites, and regulatory teams
- Development of training qualification forms and curricula for NA Quality Team
- Success Factors Administrator
- Develop Curriculum and SOP’s for NA Quality Group
- Monitor/ Modify Curriculum and Training for NA Quality Employees through My University Software (LMS).
Warehouse Manager
ECM Supply
12.2017 - 05.2018
- Management of all Shipping, Receiving, Inventory, Transportation Operations, and Customer Relations
- Management of warehouse Employee’s and Drivers
- Scheduling and Logistics
- Established operational procedures for verification of incoming and outgoing shipments through detailed tracking system
- Initiated strategic project forecasting and route planning to increase efficiency and customer satisfaction
- Troubleshoots all receiving and shipping complaints to find the cause, help resolve the issue, and prevent re-occurrence by implementing a Corrective Action and Preventative Action
- Maintains a safe and healthy work environment by establishing standards and procedures to comply with legal regulations
- Accomplishes warehouse human resources objectives by recruiting, training, and disciplining employees, communicating job expectations, reviewing job contributions, planning and reviewing compensations actions enforcing policies and procedure.
Senior Technical Training Specialist QC
Mylan
11.2013 - 12.2017
- Development of High Performance Liquid Chromatography technical training program for the Quality Control Department
- GDP, cGMP, FDA, USP
- Program Qualifications for ID, Composite Assay, Content Uniformity, Related Compound, Dissolution, Raw Material, Finished Product and Stability Testing
- Qualification and release of over 200 Chemist
- Continual training of all Qualified QC Employee’s
- Management and Development of training materials for HPLC, Sample Preparation, Instrumentation, and Software within the QC Department
- Development, Evaluations, and Revisions of SOP’s
- Liaison to QC Laboratory and Training Department to identify opportunities for Compliance Alignment and Laboratory Practice.
- Trained and mentored over 200 QC Chemist
- Coordinated training schedules across laboratories with supervisors and managers to optimize training initiatives and work-flow management
- Created and oversaw over 10 training programs for operations.
- Facilitated hands-on training sessions for employees on new software, hardware, and technology tools.
Quality Control Chemist
Mylan
10.2009 - 11.2013
- Analytical Analysis
- Data Review
- Data Processing
- Investigation of Aberrant Data
- Technical Writing
- Instrumentation
- Scheduling of Analytical Testing coordinated with release of product
- Qualification of 150 House Reference Standards.
Education
BS - Chemistry
CALIFORNIA UNIVERSITY OF PENNSYLVANIA
01.2009
BA - Art
CALIFORNIA UNIVERSITY OF PENNSYLVANIA
01.2005
Skills
- Compliance Requirements
- Course Design
- Finance
- Policy Implementation
- Learning Management Systems
- New Hire On-Boarding
- Stakeholder Management
- Coaching and Mentoring
Machine Skills
- HPLC
- Dissolution
- Karl Fisher
- Analytical Balance
- Stolle Shell Press
- Tray Balancers
- High Speed Vortex Liners
- High Speed Stolle Conversion Presses
- Auto Baggers
- Forklift
Instrumentation Skills
- Pharmaceutical Instrumentation for Testing and Data Acquisition
- High Speed Manufacturing Machinery for Production of Aluminum Ends
Timeline
Training Supervisor
Ball Corporation
05.2021 - Current
Senior Technical Training Specialist QA
Mylan
07.2020 - 05.2021
Senior Specialist Change Control NA Quality
Mylan Pharmaceuticals
05.2018 - 06.2020
Warehouse Manager
ECM Supply
12.2017 - 05.2018
Senior Technical Training Specialist QC
Mylan
11.2013 - 12.2017
Quality Control Chemist
Mylan
10.2009 - 11.2013
BS - Chemistry
CALIFORNIA UNIVERSITY OF PENNSYLVANIA
BA - Art
CALIFORNIA UNIVERSITY OF PENNSYLVANIA
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