LAUREN LIGON
Arden
Summary
Senior Specialist, Quality Systems & Compliance with over 8 years of experience in quality control and laboratory compliance. Extensive background in performing analysis and documentation adhering to GMP, FDA, ISO 9001, and GLP standards. Responsible for internal audits, compliance reporting, and document control in prior roles. Aims to leverage meticulous detail and robust analytical skills to ensure system compliance and risk management.
Overview
10
10
years of professional experience
Work History
Quality Control Specialist
DANCHEM TECHNOLOGIES INC.
03.2020 - 04.2022
- Performed analysis and documentation of raw materials, intermediates, and final packaged materials using HPLC, GC, FTIR spectroscopy, and Karl Fischer titration methods ensuring compliance with FDA, GMP, and ICH regulations
- Created, approved, and analyzed Certification of Analysis (CoAs) for tanker truck transport, raw material usage, and final packaged materials based on ISO 9001 standards
- Collaborated with engineers, operators, and management to adjust raw materials using pH adjustments, solvent analysis by GC, PT-CO color measurements, and other analytical techniques
- Administered Out of Spec (OOS) investigations through additional analytical testing and ensured unexpected events were handled according to compliance standards
- Performed calibrations, maintenance, and troubleshooting on all instrumentations; responsible for the preparation of mobile phases, standards, titrants, and other chemical solutions as needed
- Reviewed and approved certificates of analysis ensuring GMP, FDA, and ICH compliance
- Reported results using laboratory notebooks and the Quality Management System (QMS), supporting global audits and inspections
- Performed batch rework in accordance with deviation and investigation review
Assistant Scientist (Curation)
METABOLON INC.
06.2019 - 12.2019
- Interpret mass spectrometry data in an effort to properly identify the presence of metabolite compounds in each sample set for quantification and statistical analysis
- Utilize variables such as retention, relative intensity, mass, and fragmented ions (MSMS) to accurately determine the data that can be used for quantification
- Utilize pharmaceutical and microbiology knowledge to determine compound presence of pharmaceutical compounds
- Report any obscured findings to management or quality control using Laboratory Information Management System (LIMS) and ensure compliance with all GLP standards
Technologist (Microbiology)
LABORATORY CORPORATION OF AMERICA (LABCORP) HOLDING
07.2018 - 04.2019
- Observe under light microscopic conditions the presence of mycobacteria spp
- The presence of Nocardia spp
- Or non-mycobacteria such as fungal elements and various species of bacteria
- Inoculate medium for the recovery of mycobacteria spp
- To recover isolates for the aid in AccuProbe, DNA sequencing, and antibiotic susceptibility testing
- Perform culture readings for bacterial, fungal, AFB specimens
- Assist with processing of specimens per acceptance criteria standards
- Report results to doctors using technical decisions for GLP operations and ensuring regulatory compliance
Biologist II
MERCK
09.2016 - 10.2016
- Under microscopic conditions observe cell culture flasks to detect the presence of viability and underlying variances that could lead to the load being rejected
- Monitor cellular division in an effort to harvest cells for recombinant DNA
- Perform procedures per Standard Operation of Procedures for cell harvesting, utilize hemocytometer for automated cell counting, and freeze cells in cryovial using liquid nitrogen
Quality Control Microbiologist I
FUJIFILM DIOSYNTH BIOTECHNOLOGIES
11.2015 - 02.2016
- Perform bioburden testing on facility waters, equipment rinses, and client antigen or liquid eluates
- Perform routine nonviable, viable, and contact environmental monitoring for manufacturing suites in order to monitor environmental conditions in an effort to reduce contaminations and support manufacturing in-process methods
- Perform endotoxin testing on facility waters, equipment rinses, and client antigen or liquid eluates for Bacterial Endotoxin Testing (BET) and susceptibility testing
- Serve as support within the laboratory through routine duties, review of data in LIMS, plate reads, return to service environmental monitoring and any support to help aid manufacturing for GMP compliance
Microbiology Lab Technician
TELEFLEX MEDICAL INC.
03.2014 - 08.2015
- Perform investigational testing to ensure biological indicators accurately detect product sterilization
- Report data in real time using laboratory notebooks, internal logbooks, and Laboratory Management System (LMS) per FDA and GMP regulations
- Perform data review trending and technical assessments of company microbiology tests such as environmental testing, bioburden, endotoxin, B&F, residual and test of sterility testing of products and raw materials as required
- Perform microbiology technical assessments of changes to the controlled environments and related processes and products
- Reviewed and approved samples in accordance with deviation and investigation review for each non-conforming product
Pharmacy Technician
RITE AID PHARMACY
05.2012 - 04.2015
- Calculate and perform necessary conversions to ensure proper medication selections in accordance with both the prescriber's directions and the patient's medical profile
- Determine whether the patient's profile and doctor notes meet requirements for purchasing controlled medications
- Review invoices from vendors to ensure proper distribution of medications in accordance with pharmacy counts and needs
- Contact hospitals, doctor offices, and urgent cares when medications are not prescribed accurately based on patient's medication history, weight, and medical diagnosis
Education
Master of Science - Biotechnology: Bioinformatics
UNIVERSITY OF MARYLAND GLOBAL CAMPUS
Adelphi, MD12.2025
Bachelor of Science - Biology
MEREDITH COLLEGE
Raleigh, NC08.2013
Skills
- HPLC
- GC
- FTIR spectroscopy
- Karl Fischer titration
- Mass spectrometry
- Bioburden testing
- Endotoxin testing
- Certification of Analysis (CoAs)
- ISO 9001 standards
- GMP compliance
- GLP standards
- FDA/EMA regulations
- FDA regulations
- Cell culture
- Antibiotic susceptibility testing
- Environmental monitoring
Timeline
Quality Control Specialist
DANCHEM TECHNOLOGIES INC.
03.2020 - 04.2022
Assistant Scientist (Curation)
METABOLON INC.
06.2019 - 12.2019
Technologist (Microbiology)
LABORATORY CORPORATION OF AMERICA (LABCORP) HOLDING
07.2018 - 04.2019
Biologist II
MERCK
09.2016 - 10.2016
Quality Control Microbiologist I
FUJIFILM DIOSYNTH BIOTECHNOLOGIES
11.2015 - 02.2016
Microbiology Lab Technician
TELEFLEX MEDICAL INC.
03.2014 - 08.2015
Pharmacy Technician
RITE AID PHARMACY
05.2012 - 04.2015
Master of Science - Biotechnology: Bioinformatics
UNIVERSITY OF MARYLAND GLOBAL CAMPUS
Bachelor of Science - Biology
MEREDITH COLLEGE
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