Summary
Overview
Work History
Education
Skills
Timeline
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MARGI GALCHAR

Newburgh,IN

Summary

Reliable Quality Control Specialist with abilities in blueprint interpretation, operations monitoring and quality control inspections. Outstanding communication, active listening and organizational talents. Physically fit and adaptable with the capability to work in various work environments. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

8
8
years of professional experience

Work History

Senior QC Specialist

AstraZeneca
07.2023 - Current
  • Strengthened collaboration between production and quality teams by fostering open communication channels.
  • Monitored supplier performance, driving improvements in materials and components used in production processes.
  • Identified opportunities for continuous improvement through ongoing evaluation of current QC practices.
  • Enhanced reporting capabilities providing real-time insights into product quality trends, enabling informed decision-making for process improvements.
  • Trained new team members on proper usage of QC equipment, enhancing overall departmental expertise and performance.
  • Evaluated new technologies applicable to the QC field, recommending investments that led to process advancements and efficiencies.
  • Streamlined documentation processes, resulting in improved traceability and data accuracy for quality records.
  • Reduced production downtime by promptly identifying and addressing quality issues.
  • Conducted root cause analysis to pinpoint sources of product non-conformities, leading to timely corrective actions.
  • Boosted customer satisfaction by ensuring consistent product quality through rigorous testing.§ Ensures appropriate cGMP Quality Systems are in place through review and approval of documentation and delivers support in defined areas of expertise. This could include but is not limited to interfacing with QC and site departments to ensure systems, processes, facilities, utilities, equipment, and instruments are in accordance with cGMPs.
  • Trains and mentors analysts of various levels on appropriate testing technique associated with laboratory analyses.
  • Reviews laboratory analyses and executed protocols for accuracy and completeness.
  • Leads one or more multi member projects related to Quality Control continuous improvement objectives.
  • Provides Quality support and technical expertise to cross-functional groups and personnel on projects, as appropriate.
  • Supports site regulatory inspections; interfaces with Regulatory Agencies during inspections. Participates in the preparation of document packages and responses to regulatory agencies.
  • Supports the preparation of the site Annual Product Quality Review (APQR) reports in alignment with the Regulatory Annual Report schedule, Q&CM Policies and Procedures, and site SOPs within Quality Control.
  • Communicates and builds cooperative relationships with third-party colleagues and within AZ.
  • Authors, reviews, and approves documents including standard operating procedures (SOPs), protocols, deviations, CAPAs, reports, and other GMP documents as required.
  • Submit, review, and route department change controls as necessary. Coordinates the review and approval for qualification reports related to laboratory equipment and other laboratory facilities qualifications (i.e. hoods, glassware washers etc.).
  • Provide scheduling support for laboratory activities as needed.
  • Supports and delivers on Technology Transfer activities as related to Quality Control.
  • Tracks and reports key laboratory metrics as assigned.

QC Chemist

Phoenix Aromas & Essential Oils
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
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
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
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 Chem-Station
  • 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 cGMP.

Education

BS - Biochemistry

Rutgers University

MBA - Supply Chain Management

Liberty University

Skills

  • Structured Query Language mastery
  • Six Sigma methodology
  • Correction action planning
  • Materials inspection
  • Continuous Improvement
  • Performance assessment
  • SOP development
  • Software quality assurance knowledge
  • Mastery of QA methodologies
  • Sampling
  • Cost-reduction methods
  • Training material development
  • Audit processes
  • Project management
  • Expertise in project management
  • Laboratory computer systems
  • Product inspections
  • Materials testing
  • Safety procedures
  • Correction plans
  • Statistical analysis
  • Inspections and audits
  • Sampling procedures
  • Testing protocols
  • Technical writing
  • Staff mentoring in absence of manager
  • Decision-making capabilities
  • Quality control tools
  • Quality assurance expertise
  • ISO standards knowledge

Timeline

Senior QC Specialist

AstraZeneca
07.2023 - Current

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

MBA - Supply Chain Management

Liberty University

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MARGI GALCHAR