MARGI GALCHAR
Quality Control Analyst
Newburgh,IN
Summary
Dedicated Quality Control CHemist with 8+ years of experience spearheading laboratory quality oversight and regulation enforcement. Seasoned professional at leading equipment validations, investigations and documentation. Focused on driving continual improvements through assessment and proactive problem-solving.
Overview
6
6
years of professional experience
Work History
QC Chemist
Phoenix Aromas & Essential Oils
Norwood, NJ
06.2018 - 11.2021
- Conducted routine activities with moderate guidance and supervision.
- Proficient in using of Empower and exposure to the basic theory and operated principles of GC, GC-MS, Karl Fisher and flashpoint.
- Performed analytical testing of raw materials and finished product of flavors and fragrances using different analytical techniques.
- Prepared laboratory reagents, standards, and solutions for test procedures and aided others in test procedures and performed daily odor analysis to analyze samples.
- Performed analysis with having knowledge in cGMP, OSHA, FDA and other regulations in order to assure laboratory compliance.
- Evaluated laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines.
- Developed and revised laboratory SOPs as required.
- Utilized established scientific techniques to compile and analyzing data.
- Approving samples in QC software of finished samples and returned materials.
- Ensured that products are being tested strictly under cGMP conditions.
- Represented QC lab to the customer regarding supply chain project where customer onsite meeting are performed.
- Participated as a chemist in trade show of flavors to represent company with group of few people; where explanation of formulation of flavor and chemicals are involved.
- Calibrated laboratory equipment and suggested improvements of laboratory testing procedures, techniques and/or instrumentation.
- Performed duties related to the position when required by laboratory management like supporting in lab investigation.
QC Analyst II
Par Pharmaceuticals
Chestnut Ridge, NY
10.2017 - 05.2018
- With moderate guidance and supervision, conducted Routine and non-routine activities.
- Performed analytical testing of in-process control materials, stability samples, and finished product (Commercial, Clinical and Registration Batches) using different analytical techniques.
- Prepared laboratory reagents, standards, and solutions for test procedures and aided others in test procedures.
- Have working knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
- Evaluated laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines.
- Developed and revised laboratory SOPs as required.
- Diligently followed written laboratory protocols, guidelines, procedures and methods.
- Utilized established scientific techniques to compile and analyzing data.
- Prepared laboratory reagents, standards, and solutions for test procedures and aided others in test procedures.
- Ensured safety requirements are followed when performing lab testing.
- Ensured that products are being tested strictly under cGMP conditions and disposition is taken on time as per the committed production plan for every month.
- Identified creative and innovative solutions of non-routine analytical tasks.
- Calibrated laboratory equipment and suggested improvements of laboratory testing procedures, techniques and/or instrumentation.
- Performed other duties related to the position when required by laboratory management like supporting in lab investigation.
- Proficient in using of Empower and exposure to the basic theory and operated principles of HPLC, UV, FTIR, GC, and Malvern particle size analyzers.
Bio-analyst
Pfizer Inc
Parsippany, NJ
05.2017 - 09.2017
- Worked with some supervision, and applied established knowledge of laboratory techniques such as HPLC, dissolution, moisture by KF, GC, TLC, and others to perform pharmaceutical product stability testing.
- Performed analysis for drugs like dissolution, KF, assay degradation and HPLC, and computed data on Empower and LIMS.
- Used knowledge on chromatographic techniques, especially HPLC and GC.
- Performed routine analytical testing for stability samples, evaluated and documented results in a timely manner.
- HPLC Separations Module equipped with UV Detector and Alliance Software.
- Understood and followed all SOPs and written test procedures.
- Performed testing within established standard test times and maintained quality and productivity at acceptable levels as communicated by the supervisor.
- Executed troubleshooting of instrumentation and maintained laboratory equipment in good working condition.
- Performed laboratory investigation steps with appropriate approvals and with guidance from supervisor.
- Working knowledge of both computer and data handling acquisition systems.
- Strongly followed cGMP regulations.
Analytical Chemist
Takasago
Teterboro, NJ
12.2015 - 04.2017
- Performed analysis of incoming raw materials as well as finished flavor products, using instruments such as Densitometers, Refractive Index, Karl Fisher, Polarimeter, UV Spectrometer,.
- Particle Size Analyzer, ph-Meter, Flashpoint Testers, Microwave Oven Moisture Analyzers, Salt analyzer, Gas Chromatograph and HPLC.
- Performed analysis for heavy metals via ICP/MS.
- Performed daily sensory set-up for panelist to evaluate the quality of raw materials and flavor profiles of finished products.
- Worked with Regulatory affairs to improve in product safety datasheets.
- Reported safety data on weekly and daily bases with improved quality safety trials.
- Performed different trials on GC to improve in safety outcome for product existing and for new clinical trials.
- Performed monthly inspection with management in improvement in safety production and developing risk mitigation practices.
- Worked with global marketing and regulatory affairs to establish regulations impacting products with company cost savings improvement.
- Worked with Supervisor to develop a quantitative analysis method for the determination of ethanol in flavors using a multi-level calibration set of standards and ChemStation.
- Developed GC method for the quantitative determination of d-limonene and menthol in flavor mint oils.
- Performed routine GC analysis of flavor raw materials/finished flavors and evaluated generated chromatograms comparing them to standard chromatograms.
- Performed sample preparation and analysis of flavors for the determination fructose, glucose, and sucrose using Waters HPLC Separations Module equipped with Refractive Index Detector and Alliance Software.
- GC/LC Troubleshooting and Routine Maintenance including changing GC liners and septa on a monthly basis for Agilent’s 5890, 6890, and 7890 GCs.
- Changed/Installed columns when ruined or when calibration checks detected that they had run out of life cycle.
- Performed routine maintenance on HPLC, by changing pump seals and pre-column cartridges.
- Adhered to company SOPs, Lab Safety policies and cGMPs.
Education
BS - Biochemistry
Rutgers University
MS - Supply Chain Management
Liberty University
trueSkills
Structured Query Language mastery
Timeline
QC Chemist
Phoenix Aromas & Essential Oils
06.2018 - 11.2021
QC Analyst II
Par Pharmaceuticals
10.2017 - 05.2018
Bio-analyst
Pfizer Inc
05.2017 - 09.2017
Analytical Chemist
Takasago
12.2015 - 04.2017
BS - Biochemistry
Rutgers University
MS - Supply Chain Management
Liberty University