Quality Assurance Hazardous Materials
Resume:
John J. Sakal II
Baltimore, MD 443-***-**** *********@*******.***
https://www.linkedin.com/in/john-sakal-9b550a13/
Professional Summary
Experienced analytic chemistry professional with extensive training in cGMP, aseptic technique, and hazardous materials safety. Proficient in Microsoft Office Suite and LIMS. Certified in Transporting Dangerous Goods and Protecting Human Research Participants. Demonstrated history of success in various roles within pharmaceutical, environmental, and educational sectors. Strong analytical skills with a commitment to quality assurance and compliance.
Certificates Completed: cGMP Training; Aseptic Technique and Process Control; Hazardous Materials Safety; General Safety Training (OSHA Standards and Laboratory Safety); Transporting Dangerous Goods; Transporting Category A and B; Protecting Human Research Participants; cGCP (Clinical Trials Compliance)
Work History
Consultant
FAS Services, Sykesville, MD May 2017 - Present
Erosion control, environmental paperwork, excavation equipment, and other projects.
Analytical Chemist
Pharmaceutics International INC, Hunt Valley, MD Sep 2022 – Nov 2022
oAnalyzed pharmaceuticals per various pharmacopeias.
oUtilized HPLC, TOC, UV-Vis, and FT-IR, Karl Fischer (KF).
oObserving FDA and DEA drug procedures for handling narcotics.
Lab Technician (Chemist)
Mistral Inc., Nottingham, MD Nov 2021- Nov 2022
Formulate bulk chemicals for narcotics and explosive test kits.
Set up all QC and QA for all lab procedures.
Author SOP’s and SDS.
Advise on Covid-19 policies.
Upgrade the production lab to bring more manufacturing capabilities.
Set up hazardous waste disposal system.
QA Raw Material Supervisor, Contractor
The Fountain Group, Catalent Pharma Solutions, Jessup, MD (CAV 2) May 2021 – Jun 2021
oConducted reviews of cGMP documentation associated with the disposition of raw materials.
oMaintained and updated various QA trackers and spreadsheets.
oWorked cross-functionally to resolve raw material quality.
QC Raw Material, Contractor
ALKU, Emergent Biosolutions Inc., Bayview, Baltimore, MD Aug 2020 – Feb 2021
oInspected components and conducted testing of raw materials for Operation Warp Speed COVID-19 Vaccine project.
oTrained and mentored new analysts.
oReviewed and authorized data in LIMS for various tests (QA).
oSample raw materials using aseptic techniques in a class D clean room.
John J. Sakal 443-***-**** *********@*******.*** Page 2 of 3
Chemist I
Cadista Pharmaceuticals Inc., Salisbury, MD Aug 2013 – Nov 2015
oAnalyzed raw materials and final product per USP prior to release.
oSupported the management of the CAPA process and assisted in investigations.
oUtilized UV-Vis, FT-IR, HPLC (Empower III), Karl Fischer (KF), Dissolution Bath, Ether extractions.
Laboratory Technician III
Optimus Management Group LLC, Hunt Valley, MD Apr 2012 – Jul 2012
Formula test batches for cosmetics according to SOPs.
oFilled test bottles and performed analytical procedures.
oManaged raw material disposition.
Enrichment Teacher
Beth El Pre-School, Baltimore, MD Jan 2012 – Feb 2012
oIntroduced basic science for 4 & 5-year-olds; Developed lesson plans and ordered supplies.
Product Development Scientist
Taylor Technologies, Inc., Sparks, MD Nov 2004 – Nov 2011
oImplemented ISO 9001 practices and policies.
oDeveloped water test kits for various applications.
oAssisted in the development of laboratory equipment.
oUtilized UV-Vis, FT-IR, Amperometry titrator.
Supervisor, Environmental Monitoring/Raw Materials Lab
Chesapeake Biological Laboratories, Inc., Baltimore, MD Sep 2000 – May 2003
oImplemented ISO 9001 practices and policies.
oDeveloped water test kits for various applications.
oAssisted in the development of laboratory equipment.
oUtilized UV-Vis, FT-IR, Amperometry titrator. analysts in cGMP monitoring and raw materials testing.
oValidated water for injection (WFI) lines for manufacturing facilities.
oAuthored protocols for system validation.
oAnalyzed pharmaceuticals per various pharmacopeias.
oUtilized TOC, UV-Vis, FT-IR, Karl Fischer (KF), Autoclave, pH meter.
oSample raw materials using aseptic techniques in a class 10,000 room.
oEmergency build out for BL 2/3 for Smallpox vaccination project after 9/11.
oLaboratory expansion.
oLyophilization Testing (USP).
Research Assistant
Research Foundation State University of NY at Stony Brook, NY Jan 1999 – May 2000
Research of uranium-to-uranium oxide breakdown under varying conditions with citric acid.
Utilized FT-IR, X-ray Photoelectron Spectroscopy (XPS), Vacuum Ultraviolet (VUV) ring at National Synchrotron Light Source at Brookhaven National Labs.
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Education
Advanced Training in cGMP, GLP, GCP, and regulatory compliance
Clinical Research Associated (CRA) Academy, San Bernardino, CA
Bachelor of Science in Chemistry, Stony Brook University, New York
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