Gregory Sledzik
Quality Control Analyst III at Emergent BioSolutions- Claim this Profile
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Bio
Experience
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Emergent BioSolutions
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United States
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Biotechnology Research
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700 & Above Employee
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Quality Control Analyst III
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May 2023 - Present
Rockville, Maryland, United States
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Quality Control Analyst II
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Mar 2022 - May 2023
Rockville, Maryland, United States Basic understanding of compliance/guidance/regulation pertaining to assigned are. Perform routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight. Perform environmental monitoring during fill operations. Perform daily checks on equipment. Stock the lab on a regular basis. Inform Manager upon observing OOS, OOT, or deviations. Participate in investigations of OOS results and… Show more Basic understanding of compliance/guidance/regulation pertaining to assigned are. Perform routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight. Perform environmental monitoring during fill operations. Perform daily checks on equipment. Stock the lab on a regular basis. Inform Manager upon observing OOS, OOT, or deviations. Participate in investigations of OOS results and other related studies. Verify and enter results in LIMS. Practice Good Documentation per the Standard Operating Procedures. Review record keeping and documentation of laboratory equipment maintenance. Support department compliance and productivity goals. Track time worked per project. Detailed oriented – Able to complete required tasks and associated documentation with minimal error. Adaptability – Maintain positive attitude in a changing work environment. Communication – Effectively communicate with all levels of manufacturing and support staff. Escalate issues through the proper channels
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Smith+Nephew
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United Kingdom
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Control Associate - Environmental Monitoring
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Jul 2019 - Feb 2022
Columbia, Maryland, United States Perform microbiological monitoring duties including viable air, viable surface and nonviable particulate sampling of cleanroom facility Receive, incubate, and report results from environmental monitoring samples. Perform water and steam sampling of USP water system. Initiate and perform investigations for deviations and out of specification test results. Review, maintain and report anomalies pertaining to required QC records, logs and associated… Show more Perform microbiological monitoring duties including viable air, viable surface and nonviable particulate sampling of cleanroom facility Receive, incubate, and report results from environmental monitoring samples. Perform water and steam sampling of USP water system. Initiate and perform investigations for deviations and out of specification test results. Review, maintain and report anomalies pertaining to required QC records, logs and associated documents. Write and revise Environmental Monitoring Standard Operating Procedures. Provide training and certification for new employees to appropriately perform Environmental Monitoring duties. Strict adherence to Current Good Manufacturing Practices and Master Production Records. Show less
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Osiris Therapeutics
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Biotechnology Research
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1 - 100 Employee
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Quality Control Associate - Environmental Monitoring
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Mar 2016 - Jul 2019
Columbia, Maryland Perform microbiological monitoring duties including viable air, viable surface and nonviable particulate sampling of cleanroom facility Receive, incubate, and report results from environmental monitoring samples. Perform water and steam sampling of USP water system. Initiate and perform investigations for deviations and out of specification test results. Review, maintain and report anomalies pertaining to required QC records, logs and associated… Show more Perform microbiological monitoring duties including viable air, viable surface and nonviable particulate sampling of cleanroom facility Receive, incubate, and report results from environmental monitoring samples. Perform water and steam sampling of USP water system. Initiate and perform investigations for deviations and out of specification test results. Review, maintain and report anomalies pertaining to required QC records, logs and associated documents. Write and revise Environmental Monitoring Standard Operating Procedures. Provide training and certification for new employees to appropriately perform Environmental Monitoring duties. Strict adherence to Current Good Manufacturing Practices and Master Production Records.
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Lead Manufacturing Technician
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Jul 2012 - Mar 2016
Columbia, Maryland Orchestrate manufacturing staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures. Maintain work flow by monitoring steps of the process; observing control points and equipment; monitoring personnel and resources; facilitating corrections to existing processes through CAPA implementation; initiating and fostering a spirit… Show more Orchestrate manufacturing staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures. Maintain work flow by monitoring steps of the process; observing control points and equipment; monitoring personnel and resources; facilitating corrections to existing processes through CAPA implementation; initiating and fostering a spirit of cooperation within and between departments. Adapt to production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting daily results of manufacturing on shift production summaries. Process and extract stem cells from placenta and cadaveric tissue using aseptic technique. Handle human donor tissue under strict GTP, GDP, GMP, American Association of Tissue Banks Standards, State and FDA regulations, including Part 1271 Human Cells, Tissues, and Cellular Tissue-Based Products guidelines. Maintain quality service by establishing, revising, and enforcing organization Standard Operating Procedures (SOP). Construct and revise investigations, deviations and reports.
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BD
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Laboratory Technician
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Sep 2011 - Jun 2012
Cockeysville, Maryland Quality Control Investigations Create/Prepare Plated Media in a GLP environment Work with Bacterial Cultures Testing and drawing conclusions from investigations through the use of scales, balances, pH meters, etc
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MedImmune
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United States
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Biotechnology Research
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700 & Above Employee
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Production Laboratory Technician
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May 2011 - Sep 2011
Responsible for the operation of equipment according to established Standard Operating Procedures and Master Production Records for the manufacture of therapeutic proteins and vaccines in accordance with Current Good Manufacturing Practices (cGMP’s) Operation of Industrial Glasswash, Autoclave, weigh outs for Media and Buffer Solution Preparation Strict adherence to Current Good Manufacturing Practices and Master Production Records
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Target
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United States
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Retail
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700 & Above Employee
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Electronics Team Member
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May 2010 - Jun 2011
Provide a pleasurable guest experience in the Electronics, Instocks, and Backroom Logistics departments
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Lycoming College
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United States
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Higher Education
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200 - 300 Employee
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Assistant to Professor
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Feb 2009 - Dec 2009
Responsible for follow-up research from the data collection of interns during the summer and fall of 2008 Projects included Marcellus Shale Drilling monitoring, RecycleMania, Susquehanna River testing, educating the student population about environmental issues
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Intern
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Jun 2009 - Aug 2009
Responsible for data collection, analysis, and reporting of water quality in the Susquehanna River and surrounding tributaries Skills included coliform counts, field work, small animal handling, subcutaneous insertions, water testing, wet chemistry, TSS, organism identification, environmental monitoring, Excel chart preparation, Data collection and presentation Daily tasks included gathering water samples from the Susquehanna River and tributaries followed by wet chemistry tests for… Show more Responsible for data collection, analysis, and reporting of water quality in the Susquehanna River and surrounding tributaries Skills included coliform counts, field work, small animal handling, subcutaneous insertions, water testing, wet chemistry, TSS, organism identification, environmental monitoring, Excel chart preparation, Data collection and presentation Daily tasks included gathering water samples from the Susquehanna River and tributaries followed by wet chemistry tests for levels of phosphate, nitrate, nitrite, pH, alkalinity, and BOD Organism identification included identifying benthic macro-organisms as indicator species (Ephemeroptera, Plecoptera, Trichoptera, etc) using kick nets, Hester Dendy samplers, and rock baskets Cromaglass research to assess the ability of the Cromaglass system located at the Williamsport Waste Treatment facility Electrofishing techniques used to assess the health of specific waterways based on the diversity of fish species present Co-operative work with Show less
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Education
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Lycoming College
Bachelor of Science, Biology; Environmental Science