Sandra Carter
Augusta,Georgia
Summary
Dynamic Senior Training Specialist and Documentation Assistant with a proven track record at Monsanto, Eli Lilly, Monsanto and Union Agener Pharmaceuticals. Excelled in training and Quality Assurance documentation and development. Expert in managing learning and documentation management systems and ensuring compliance with cGMP standards. Recognized for exceptional attention to detail and effective training and documentation evaluations, driving organizational success through impactful training and documentation initiatives.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Senior Training Specialist
Union Agener
10.2018 - 05.2023
- Processed thousands of training credits and managed learning management system content (SE Suite).
- Maintained hundreds of training configurations within the training system.
- Developed approximately 900 training curriculum based on training requirements.
- Evaluated and assured two training support systems (Standard Operating Procedures (SOPs), files, etc.) were implemented and adhered to; partnered with areas within the site for issuance of training material.
- Created and maintained thousands of online test surveys, Courseware (document) creation, revision, review and released, in coordination with Quality (QA) Documentation Team.
- Provided Quality oversight and Current Good Manufacturing Practices (cGMP) mindset for adherence to hundreds of training and site procedures.
- Handled other documentation tasks and projects as assigned.
- Supported and delivered Training for New Employee Orientations (NEO).
- Supported audit requests for training evidence.
Senior Assistant, Quality Assurance Documentation
Eli Lilly and Monsanto
05.2003 - 10.2018
- Assisted Quality Assurance (QA) Manager in implementing a system for complete documentation of all required records, logs, and instructions necessary for compliance with Current Good Manufacturing Practices (cGMP).
- Coordinated appropriate activities in the control and maintenance of the QA documentation system for cGMP operations.
- Ensured proper code numbers were assigned to documents according to standard written procedures.
- Ensured documents were generated. reviewed, approved, and issued according to written procedures.
- Ensured changes to the documents were handled according to approved change control procedures.
- Ensured originators/responsible individuals for specific departments were notified and provided with a listing of documents for annual or periodic reviews.
- Maintained history files of all documents including the document change requests (DCR), supporting documentation, and annual reviews.
- Maintained all databases in support of the QA Documentation System.
- Maintained the system for the issuance of production batch records and the maintenance of completed production batch records.
- Maintained history files for all commercial documents.
- Ensured a system for quick retrieval of documents in the QA Documentation System.
- Ensured approved Standard Operational Procedures (SOP) were distributed throughout the facility, and all previous versions were retrieved and properly destroyed.
- Assisted personnel with request for copies of documentation.
- Audited Portable Document Format (PDF) System documents before releasing documents for publication.
- Provided Regulatory Affairs with needed documents for regulatory submissions, and requested documents during regulatory inspections.
- Published controlled documents in PDF format for on-line viewing.
- Assisted QA Archive Coordinator with off-site archiving of controlled documents.
- Responsible for the maintenance, management, and coordination of all activities within the QA Documentation System.
- Handled change productively and handled other tasks as assigned.
Education
Bachelor of Arts - Business Administration, Management
Strayer University
Augusta, GASkills
- Customer Service
- Training Documentation
- Attention to Detail
- Time Management
- Training and Development
- Training Databases
- Training Evaluation
- Information System Management
- Microsoft Office Software
Accomplishments
- Trained more than 300 full time associates, to include mangers and team leaders.
- Documented and resolved documentation training and software cliches which led to the efficiency of employee trainings evaluations.
- Supervised team of four staff members.
- Collaborated with team of 15 in the development of Regulas Documentation and Training System Projects.
Certification
- Certified Training Specialist for Union Agener Pharmaceuticals, 2018-2023.
Languages
English
Full Professional
Affiliations
- Diversity and Inclusion
Annual Bonus Supplements
- Received monetary self development and safety recognitions in addition to profit sharing bonuses.
- Receive on-the-spot monetary awards for above and beyond work performance.
Timeline
Senior Training Specialist
Union Agener
10.2018 - 05.2023
Senior Assistant, Quality Assurance Documentation
Eli Lilly and Monsanto
05.2003 - 10.2018
Bachelor of Arts - Business Administration, Management
Strayer University
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