Amanda Benefield
Saint Joseph
Summary
Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combines strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.
Overview
6
6
years of professional experience
Work History
Learning Administrator
Elanco Animal Health
11.2022 - Current
- The QA Associate provides daily assistance and guidance to maintain site Quality Systems. The QA Associate is responsible for working with line management to establish and administer the training program for the Elwood, KS site. This individual serves as the point person for L&D and will serve as a Doc Controller within the Electronic Document System at the Elwood, KS site. The QA Associate works as a QA team member to ensure product and site compliance with cGMP and Elanco requirements and achieve site goals while maintaining a strong quality mindset.
- Functions, Duties, Tasks:
- Provide support to the site for Veeva Quality Vault as a Document Controller
- Work with line management in analyzing and designing courses/curriculum
- Assist with Instructor Led Trainings-prepare materials and process Learning History Requests
- Ensure overall consistency and compliance of the site training program
- Maintain required training forms and files
- Responsible for creating and coordinating visitor training requirements
- Participate in deviation and change control process to understand the issues, evaluate training opportunities, and assist leaders with determining the required level of training needed
- Training Metrics— Reporting on training compliance as necessary
- Coach supervisors and learners on how to use Success Factors, Service Now, and Veeva Vault Quality
- Work with area mentors/SME’s to support on-the-job training
- Strong partnership and communication with cross functional areas
- Provide Customer Support on Success Factors
- Recommend, implement, and evaluate L&D Solutions, including defining instructor qualifications, coordinating, or conducting train-the-trainer sessions, course evaluations
- Lead, mentor, and coach operations and support personnel on quality, training and/or document control matters
- Provide guidance to ensure robust quality systems and compliance
- Provide support during internal/external regulatory inspections
- Effectively review/approve controlled documents to ensure quality attributes are met (i.e., non-conformances, procedures, technical studies, validation protocols, change controls, engineering documents, etc.)
- Assist partners with writing change controls, deviations, and performing investigations
- Mentor and coach site personnel on Quality matters
- Assist with implementation and ensure adherence to the EGQSs
- Assist with the day-to-day Quality operational activities (batch disposition, compliance checks, material handling)
- Serve on project teams, as assigned, to provide Quality and compliance guidance and input
- Other duties as assigned
QA Document Control Specialist
Elanco Animal Health
01.2022 - 11.2022
- Initiate, route, and approve controlled documents. File completed documents in approved paper and electronic locations.
- Review and/or format all new/revised GxP documentation for compliance with document management SOP(s).
- Ensure that document periodic review is conducted as required.
- Maintain awareness of current regulatory expectations and industry standards.
- Participate in internal and external audits and regulatory inspections as required.
- Follow all Good Documentation Practices and cGMPs to ensure compliance to applicable guidelines.
- Issue training notifications for all new and revised GxP documents. Track training completion and issue reminder notifications.
- File completed training records in personnel training files.
- Maintain internal Quality Systems in support of manufacturing.
- Participate in change controls, deviations, CAPAs, and documentation reviews.
- Initiate and review specifications and provide quality support to the supplier program.
QA Document Control Specialist
Kindred Biosciences, Inc.
04.2021 - 12.2021
- Initiate, route, and approve controlled documents. File completed documents in approved paper and electronic locations.
- Review and/or format all new/revised GxP documentation for compliance with document management SOP(s).
- Maintain awareness of current regulatory expectations and industry standards.
- Participate in internal and external audits and regulatory inspections as required.
- Follow all Good Documentation Practices and cGMPs to ensure compliance to applicable guidelines.
- Issue training notifications for all new and revised GxP documents. Track training completion and issue reminder notifications.
- File completed training records in personnel training files.
- Maintain internal Quality Systems in support of manufacturing.
- Participate in change controls, deviations, CAPAs, and documentation reviews.
- Initiate and review specifications and provide quality support to the supplier program.
QC, Microbiology
Kindred Biosciences, Inc.
03.2020 - 04.2021
- Conduct routine and non-routine Microbiology based analysis of raw materials, in-process materials, finished goods, and stability samples.
- Perform routine and non-routine environmental monitoring (air viable, air non-viable, and surface sampling) of manufacturing environments.
- Perform monitoring of utilities to include WFI, USP Water, Pure Steam, and Clean Compressed Air.
- Conduct microbiology testing to include total organic carbon, conductivity, endotoxin, bioburden, growth promotion, mycoplasma, sterility, microbial identifications, gram stains, and personnel sampling.
- Achieve and maintain gowing qualification for sterile environments.
- Execute gowing qualifications for personnel performing activities in classified sterile environments.
- Provide production support and participate in production fills and aseptic process simulations. Maintain QC Microbiology inventory, perform daily temperature checks on necessary equipment, and perform weekly cleaning of laboratory spaces.
- Ensure the QC lab is held to cGMP, safety, and environmental standards. Generate and report accurate data that meet regulatory compliance.
- Assist in preparation of Certificates of Analyses, OOS/OOT Investigations, EM and Facility Investigations, and Deviations during testing.
- Assist in developing and qualifying/validating new testing methods and method transfers. Write and revise testing methods.
- Assist in the development of specifications and justification of specifications. Assist in preparation of QC standard operating procedures and forms.
- Support equipment validation, calibration, and maintenance.
- Assist in preparation of method validation protocols/reports and other analytical study reports.
- Assist in the recommendation of new technologies and methods.
Education
Bachelor of Science - Biology
12.2006
Skills
- Friendly, positive attitude
- Teamwork and collaboration
- Customer service
- Problem-solving
- Time management
- Attention to detail
- Flexible and adaptable
- Dependable and responsible
- Multitasking Abilities
- Computer skills
- Organizational skills
- Organization and time management
- Verbal communication
Timeline
Learning Administrator - Elanco Animal Health
11.2022 - Current
QA Document Control Specialist - Elanco Animal Health
01.2022 - 11.2022
QA Document Control Specialist - Kindred Biosciences, Inc.
04.2021 - 12.2021
QC, Microbiology - Kindred Biosciences, Inc.
03.2020 - 04.2021
Missouri Western State University - Bachelor of Science, Biology