Laura Fields
Sabillasville,MD
Summary
Dependable Coordinator provides excellent management support. Possesses strong communication and interpersonal skills with demonstrated ability to manage competing priorities and meet deadlines. Creative problem solver with strong analytical and critical thinking skills. Self-motivated and brings proven leadership, organizational and customer relations skills. Independently solves problems and keeps teams on task to handle diverse business requirements.
Overview
11
11
years of professional experience
1
1
Certification
Work History
US Car-T Coordinator
Jannsen Pharmaceuticals
Remote
08.2021 - Current
- Demonstrates ability to proactively identify solutions to improve processes
- Lead high level meetings with stakeholders (CarT and Lenti project)
- Track and manage ECL samples and lead ECL meetings when applicable
- Back up for ECL (BioReliance)
- PO generation and tracking
- Generation of CoA’s for Lenti project
- Planning of Lenti lot release
- Liaise with samples coordinators at external manufacturers to schedule and execute samples shipments to NCL/OMCLs/ECL’s (National Control Laboratories/Official Medicines Control Laboratories)
- Liaise with samples coordinators at NCL/OMCLs (National Control Laboratories/Official Medicines Control Laboratories)
- Liaise with distribution centers in USA and EMEA
- Schedule shipping route verification studies and review/approve shipping route verification reports to validate shipping lanes across network
- Advise on product disposition when any discrepancies arise
- Ensure samples are tracked in eLIMS accurately and in a timely manner
- Lead process improvement initiatives to streamline samples sending/receipt processes in USA and EMEA
- Manage process for sending/receiving backup samples as needed
- Complete lot release protocol documentation and submit to health agencies
- Author SOP’s and work instructions with process improvements
- Lead investigations internally
- Complete and pass all applicable training required for access to quality and information management systems (i.e
- ETS Trackwise, eLIMS etc.)
- Complete and pass all applicable Good Manufacturing Practice training and general quality management training
- Learning and remaining current with local regulations, guidelines and quality practices associated with the vaccines industry is required.
QC Sample Coordinator
AstraZeneca
Frederick, MD
11.2012 - 08.2021
- Participate in the authoring or reviewing sections of regulatory submissions related to critical reagents
- In alignment with department/company strategic initiatives, influence and implement technology upgrade and continuous process improvements
- Act as qualified trainer of those with less experience
- Conduct in-direct supervision of others in the team
- Extensive equipment knowledge to perform trouble shooting and root cause analysis
- Develops solutions to complex problems requiring resourcefulness and creativity/innovation and ensures solutions are consistent with organization’s objectives
- Work is performed without appreciable direction while exercising considerable latitude in determining objectives and approaches to assignment
- Good organizational skills, first-line management skills for daily operation, situational Leadership and decision-making skills
- Manage authoring, review and approval of all technical documents, qualification protocols, SOPs, reports, Quality Control Testing Plans, Master Specs, and Certificates of Analysis as well as the coordination of all lab work necessary to complete qualifications on time
- Contributes to the development of new concepts, techniques, and standards including expert knowledge of cGMP standards, and the current Code of Federal Regulations (CFR)
- Lead Lean Labs initiative including 5S, Minimizing WIP, Process flow, minimizing cost, and improve the economic efficiency of an organization/Lab
- Responsible for performing functions and training of tasks which include: Drug Product log in and distributing to labs and outside testing labs
- Receipt of final product at FMC
- Disposal of all samples
- Aliquoting of all samples for testing
- Maintaining freezers with backups and reserves
- Reserve and back up audits Internal and External
- Review of logbooks/Archive
- SOP revisions
- Shipping of materials to different locations for testing
- Purchaser of all PO’s regarding testing for FB
- Cancellation of samples in LIMS
- AdHoc log in of samples
- Produce, maintain, and lead GCM complaints in trackwise for Drug Product shipments from external sites for the site
- Maintain and manage reserves of DP and DS product for site
- Work with Stability program by helping with pulls and aliquoting of product DP and DS
- Work and coordinate with TPN product holders for inventory access for testing support
- Managing and delivering QC’s critical reagent inventory for specific assays and tests for all products in house
- Lead and manage preventive maintenance of freezers and incubators in all buildings
- Write and adhere to on the job trainings
- Write deviations in Trackwise and lead problem solving tools
- Write and produce CAPA’s
- Lead internal and external Audits
- Produce Standard work cards
- Autoclave and washer subject matter expert
- GQCLIMS subject matter expert
- Manage all OTL PO’s and shipping of samples to OTL sites
- Testing support for labs.
Education
Bachelor of Science - Biotecnology
UMUC
Online12.2008
Skills
- Managing customer expectations
- Document controls
- Time management
- Cross-functional training
- Quality control/assurance
- Vendor relationships
- Organization and lab management
- Regulatory compliance
- Teamwork/management
- Process improvement
- Data management
- Change management
- Work Planning and Prioritization
- Relationship Building
- Process Improvement
- Project Support
Programs Efficient In
- MODA
- ELIMS
- TrackWise
- IBUY
- SAP
- HMI Systems
- Adobe
- Word/Excel/One Note
- PowerPoint
- Visio
- USP, JP, EP Online
- Microsoft Teams
Career Accomplishments
- Yellow Belt Certified 2014
- Green Belt Certified 2018
Certification
Green Belt
Yellow Belt
Timeline
US Car-T Coordinator
Jannsen Pharmaceuticals
08.2021 - Current
QC Sample Coordinator
AstraZeneca
11.2012 - 08.2021
Bachelor of Science - Biotecnology
UMUC