Experience

PCI - Calibration, Commissioning and Consulting

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• CQV Specialist II

  • May 2023 - Present

  • Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments independently. • Created, reviewed, and approved various documentation for final approval to provide client support for projects. • Interacted with clients to identify CQV needs to plan and implement solutions that meet their schedule, cost, and quality expectations. • Qualified and calibrated analytical equipment ranging from LC’s and GC’s to spectrophotometers and dissolution baths. • Utilization of Kneat for various clients. Kneat Level One Power User Certified. • Initiated deviation investigation reports and recommended CAPA’s. • Lead team to perform system walk downs to initiate a change control process. • Developed job plans to complete maintenance and PM’s. • Leads, project, planning, management, execution, and follow up efforts to ensure projects are on time, within scope, within budget and meet customer expectations. • Identified and documented scope changes and obtained approval from customers before execution. Show less



PSC Biotech Corporation

• United States
• Biotechnology
• 300 - 400 Employee

• QC Chemist II

  • Mar 2021 - May 2023

  Client site Pennsylvania (5 Months): • Performing process engineering and assisting in re-qualification studies of 140 freezers/fridges including ultra-low temperature chambers.• Using the Kaye validator equipment/software to validate cold chambers. • Using Lives International equipment/software to validate cold chambers. • Certified in Lives International Thermal Validation systems. • Performed data analysis with proper GDP/GMP skills. Client site Pennsylvania (15 Months): • Performing Quality Assurance review of different processes including Tech Transfer, Method Validation, IOPQ/IOQ, Deviations for Quality Control (QC) as a Quality Assurance Engineer.• Offer QA assistance in PLI/PAI FDA inspection.• Assisted on deviations, CAPA’s, and LIR/MIR’s.• Performed review of out of specification observations throughout the facility for EM and Analytical. • Breath of experience in deviation management writing while assisting as a customer QC/QA consultant.Client site Maryland (4 months): • Created Master Batch Records (MBR’s) for different processes in the filling/packaging respect of the site. • Wrote deviations and performed on-hand observations on the floor for corrective actions. Show less

• QC Chemist I

  • Aug 2020 - May 2023

  Client site Maryland (4 months): • Created/reviewed Master Batch Records (MBR’s) for different processes in the filling/packaging respect of the site. • Wrote deviations and performed on-hand observations on the floor for corrective actions. Client site Raleigh (6 months): • Subject Matter Expert (SME) in understanding work relations regarding cGMP guidelines and pharmaceutical/biotech unit operation. • Performed validation work related to analytical instrumentation such as: HPLC, FTIR, GC, and Karl Fischer titrators.General• Exceptional writing skills to author and execute various validation/verification documents, develop SOP’s/methods, creating final reports, and author validation and quality policies, procedures, and guidelines. Show less



Pfizer

• Events Services
• 1 - 100 Employee

• QC Chemist

  • Aug 2017 - Jul 2020

  Project Management: • Effectively managed the Nimenrix project, and for site products present and on the horizon; provided business organization throughout the team. • Managing the QC laboratories analytical Standards/Controls/Critical Reagents system suitability program (e.g. statistical analysis/trending, availability, qualification, distribution and storage). • Serve on cross functional (Standards/Controls/Critical Reagents) teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network. LIMS: • LIMS (5.0 & 7.0) management of standards, controls and critical reagents. • Responsible for detailing requirements for LIMS builds and business reviewing LIMS builds. General Tasks: • Ship and receive international and domestic materials weekly. • Performed tasks associated with maintaining GMP compliant Quality Control and Stability laboratories with a specific focus on standards/controls/critical reagents preparation, program management (multiple personnel) and implementation. • Performs tasks associated with maintaining cGMP compliant Quality Control laboratories (e.g. 5S inventory management). • Analyzes and interprets results, makes decisions regarding results, performs data trending, performs data analysis, and facilitates meeting to discuss results and develop CAPA (e.g. EM trending, Bioburden trending, utilities trending, etc.) Show less



ITG Brands

• United States
• Manufacturing
• 700 & Above Employee

• Chemist

  • Jan 2017 - May 2017

  • Performed various duties associated with the transition with documentation and organization. • Helped with auditing several labs and/or methods to become ISO/IEC 17025 and ISO 9001 re – certified. • Logged different methods and unleashed a bottleneck in sample control. • Created validation projects and specifications in Labware LIMS. • Understanding and utilized the GCMS and TQMS methods for a quick throughput for the customer. • Used Mass Hunter to analyze results to present to the customer. Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Scientist

  • Jan 2016 - Sep 2016

  • Performed Method Transfers and Validations among other testing for different clients from around the world. • Searched for small molecular structures and weights via Triple Quadruple Mass Spectrometer (AB Sci Ex 5000) through chromatographs and data extracted for reports. • Ran Agilent HPLC daily via totalchrom and empower. • Ran dissolution, UV, Karl Fisher, and Elisa Assay related testings. • Performed Method Transfers and Validations among other testing for different clients from around the world. • Searched for small molecular structures and weights via Triple Quadruple Mass Spectrometer (AB Sci Ex 5000) through chromatographs and data extracted for reports. • Ran Agilent HPLC daily via totalchrom and empower. • Ran dissolution, UV, Karl Fisher, and Elisa Assay related testings.



Novartis Vaccines

• United States
• Wellness and Fitness Services

• Analytical Scientist

  • Oct 2015 - Dec 2015

  • Executed various analytical methods, such as colorimetric methods, SDS-PAGE, HPLC, on various process samples generated at commercial scale and in the MS&T laboratories. • Reviewed and managed in-process and analytical data generated at both lab and commercial scale within Labware LIMS. • Contributed to preparation of SOPs and protocols for lab operations. • Evaluated and proposed improvements to current analytical methods to increase robustness and decrease cycle time. • Used data to support data analysis, presentations and provided technical report writing. Show less



Rapha Primary Care Ctr

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Toxicology Chemist

  • May 2015 - Oct 2015

  • Operate the Immtox machine to discern a qualitative result on a twenty-one drug panel. • Maintain laboratory reagents/equipment are up to stock/standards on a weekly basis. • Record meticulous documentation through a LIMS system for the clinic. • Operate an LC/MS nitrogen based machine 6420 for a quantitative result. • Stay in compliance with Cola/CLIA licenses • Operate the Immtox machine to discern a qualitative result on a twenty-one drug panel. • Maintain laboratory reagents/equipment are up to stock/standards on a weekly basis. • Record meticulous documentation through a LIMS system for the clinic. • Operate an LC/MS nitrogen based machine 6420 for a quantitative result. • Stay in compliance with Cola/CLIA licenses



Sold and Rented Real Estate

• General Contracter

  • Oct 2014 - May 2015

  • Fix houses via painting, fixtures, and appliances to a condition to place back on the market for renting. • Show houses for rent/sale • Fix houses via painting, fixtures, and appliances to a condition to place back on the market for renting. • Show houses for rent/sale



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Chemist

  • Mar 2014 - Oct 2014

  Running several different tests on raw finished product to keep it up to code by using HPLC, UV, Spectroscopy, and simple pipette skills. Wrote meticulous notes regarding each experiment that I performed within FDA regulations. Running several different tests on raw finished product to keep it up to code by using HPLC, UV, Spectroscopy, and simple pipette skills. Wrote meticulous notes regarding each experiment that I performed within FDA regulations.



Cape Fear Pain and Laser

• Lead Medical Technician

  • Aug 2012 - Jan 2014

  • Operating the Viva-E machine using Aqueous based HPLC techniques to discern a negative/positive drug result of moderate & intensive processes • Performed analytical testing using GC techniques used to determine drug use consumption and their metabolite. • Collect specimen from patients and record • Maintain everyday schedule of the clinic including PA’s • Obtain samples from patients • Maintain laboratory reagents/equipment are up to stock/standards • cGMP with regulatory compliance Show less



LabCorp

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Extractionist

  • Jun 2011 - Oct 2011

  • Raw drug samples : Methadone, Opioids, Tramadol, Fentanyl and THC • cGMP every day with sample batches • Utlized LIMS for data entry of various activities • Performed UV and GC techniques to separate and analyze different drugs to realize the consumption or lack thereof. • Protein purification was used in the extractions as well by filtration. • Washed Glassware • Raw drug samples : Methadone, Opioids, Tramadol, Fentanyl and THC • cGMP every day with sample batches • Utlized LIMS for data entry of various activities • Performed UV and GC techniques to separate and analyze different drugs to realize the consumption or lack thereof. • Protein purification was used in the extractions as well by filtration. • Washed Glassware



UNCW-WORK STUDY

• Data Entry

  • Aug 2010 - May 2011

  Office Assistant Office Assistant



SONI RIDER REAL ESTATE

• Data Entry

  • Jun 2009 - Aug 2009

  Word, Excel, etc. Meet and Greet Word, Excel, etc. Meet and Greet

• Office Assistant

  • Aug 2008 - Jun 2009

  HELPING THE GRAD STUDENT PREPARE BLUE CRABS FOR SURGERY Electrophoresis Filing Data Entry and Grading HELPING THE GRAD STUDENT PREPARE BLUE CRABS FOR SURGERY Electrophoresis Filing Data Entry and Grading


NEW DELI SANDWICH SHOP
• DEVELOPMENT

  • Jun 2008 - Aug 2008


SUBWAY SANDWICH SHOP

• United States
• 1 - 100 Employee

• Chef

  • Jun 2005 - Aug 2007

  Created Sandwiches Created Sandwiches