Crystal Weech
Crystal
Summary
Accomplished LIMS specialist with expertise in software implementation and business analysis. Excellent at transforming complex handwritten data into electronically captured records. Recognized for exceptional mentoring abilities and adept at fostering stakeholder relationships.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Sr. Professional Services Consultant
Clinisys
07.2024 - Current
- Engaged key stakeholders to align project scope with customer expectations.
- Performed formal customer training on system use.
- Configured the system to meet the specific laboratory requirements, using out-of-the box solutions whenever possible.
- Wrote assessment reports on current laboratory processes and how CLS can automate those processes.
Sr. Laboratory Software Specialist
Lifecore Biomedical
02.2022 - 07.2024
- Lead product rollouts that converted paper processes to electronic, from the point of sample login through reporting and disposal.
- Created custom solutions using LIMS Basic code when necessary.
- Integrated direct-transfer instruments such as pH meters, balances, osmometers, etc. to reduce and eliminate transcription errors.
- Followed change management procedures to fulfill user ticket requests regarding issues or new functionality requests. Wrote and executed test scripts and validation reports.
- Created and revised documentation (SOPs, URS, FRS, Traceability Matrices, and training materials).
- Provided user training, on-call support during off hours, and hyper care after new rollouts.
- Performed activities related to the routine maintenance of the Environmental Monitoring, Lot Manager, and Stability modules.
- Created new Crystal reports and SQL queries.
- Acted as a mentor for less experienced administrators.
LIMS Business Analyst
Takeda Pharmaceuticals
11.2019 - 02.2022
- Configured and maintained LabWare LIMS in support of QC in-process/release testing, inventory management, Stability, and Environmental Monitoring.
- Overhauled existing products to align LIMS with current master data documents.
- Managed CAPAs and change requests for enhancement requests and issues.
- Participated in planning meetings for global LIMS project.
LIMS Administrator
Lifecore Biomedical
12.2017 - 11.2019
- Independently configured LabWare LIMS v7 Pharma Template DEV instance for lot release and Environmental Monitoring.
- Recommended out-of-the-box functionality when applicable while exploring LIMS Basic for essential custom solutions.
- Designed Crystal reports (lot results reports, CoAs, and Stability data tables reports).
- Drafted and refined validation documents, including IQ/OQ/PQ, FRS, URS, and the Validation Master Plan.
- Drafted SOPs, training documents, and work instructions.
LIMS Administrator
CIMA LABS INC.
01.2015 - 12.2017
- Completed routine upkeep and improvement initiatives within laboratory informatics platforms such as LabWare LIMS, NuGenesis ELN/SDMS, and Empower.
- Coordinated with vendors to address application problems.
- Created, tested, and maintained static data in LabWare LIMS (analyses, product specifications).
- Delivered comprehensive training sessions on upgrades, features, and process enhancements.
- Served as knowledgeable resource offering guidance to end-users.
Research Associate VI
CIMA LABS INC.
01.2013 - 01.2015
- Earned Employee of the Month, August 2014 for exceptional efforts in meeting partner deadlines.
- Conducted research on systems and vendors to integrate UHPLC technology at CIMA.
- Implemented advanced techniques for impurity detection using a Waters H-class UPLC.
- Mastered operation of Senterra Raman spectrometer for investigative purposes.
Research Associate IV
CIMA LABS INC.
01.2009 - 01.2013
- Led an upgrade to Empower 2 FR 5, wrote and assisted with the execution of test scripts, collaborated with Validations and QA departments to schedule validation activities and complete documentation.
- Oversaw and maintained records of reference standards.
- Created and verified custom calculations for sister site's unique needs.
- Handled lab assignments contributing to project development.
Research Associate III
CIMA LABS INC.
01.2006 - 01.2009
- Led a team of Empower Subject Matter Experts.
- Prepared updated job training guides to enhance workforce proficiency.
- Developed skills in drafting comprehensive method validation documents.
- Served as administrator for reference standards.
Research Associate II
CIMA LABS INC.
12.2002 - 01.2006
- Conducted method transfers to Eden Prairie sister site.
- Developed and validated HPLC methods.
- Executed related substances, FTIR, Karl Fischer, and USP disintegration tests.
- Trained new analysts.
Education
Bachelor Of Science - Chemistry
University of Minnesota, Duluth
Duluth, MN05.2001
Skills
- Software implementation
- Business analysis
- SDLC
- SQL
- Oracle
- HPLC
- UHPLC
- Crystal Reports
- Telerik Reports
- Microsoft Office Suite
Certification
LabWare LIMS Administration 1
LabWare LIMS Administration 2
LabWare ELN V4
Instrument Integration Using LabStation
Timeline
Sr. Professional Services Consultant
Clinisys
07.2024 - Current
Sr. Laboratory Software Specialist
Lifecore Biomedical
02.2022 - 07.2024
LIMS Business Analyst
Takeda Pharmaceuticals
11.2019 - 02.2022
LIMS Administrator
Lifecore Biomedical
12.2017 - 11.2019
LIMS Administrator
CIMA LABS INC.
01.2015 - 12.2017
Research Associate VI
CIMA LABS INC.
01.2013 - 01.2015
Research Associate IV
CIMA LABS INC.
01.2009 - 01.2013
Research Associate III
CIMA LABS INC.
01.2006 - 01.2009
Research Associate II
CIMA LABS INC.
12.2002 - 01.2006
Bachelor Of Science - Chemistry
University of Minnesota, Duluth
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