Experience

Vector BioMed, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Control Supervisor (Microbiology)

  • Aug 2023 - Present

  Gaithersburg, Maryland, United States -Devise, implement, and maintain the QC Environmental Monitoring program/procedures -Coordinate with Facilities/Manufacturing to schedule routine maintenance and Environmental Monitoring support for upstream, downstream, and final fill operations -Assist Validation to ensure all new/existing laboratory regulation remains in compliance with regulatory guidelines -Oversee on-the-job (OJT) training of new personnel as well as annual requalifications of existing personnel… Show more -Devise, implement, and maintain the QC Environmental Monitoring program/procedures -Coordinate with Facilities/Manufacturing to schedule routine maintenance and Environmental Monitoring support for upstream, downstream, and final fill operations -Assist Validation to ensure all new/existing laboratory regulation remains in compliance with regulatory guidelines -Oversee on-the-job (OJT) training of new personnel as well as annual requalifications of existing personnel -Review raw Environmental Monitoring data as well as internal test method data to facilitate release of client drug product -Author/revise Standard Operating Procedures, Sampling Plans, Test Methods, Material Specifications, and various other controlled documents -Track and trend organism recovery to qualify and maintain an up-to-date stock of in-house environmental isolates for quality control testing -Lead investigations for quality records/compliance events to ensure generation/timely closure of CAPAs/Change Controls/Deviations/EMIs/OOS to meet site Quality Metric goals -Perform Static/Dynamic Environmental Monitoring in Grades B-D (Iso 5-8), including Fill/Finish activities and operations in the Grade A BSCs -Execute in-house Growth Promotion/Sterility of all received materials to facilitate the QC release of all media as well as Turbidity/Growth Promotion for Media Fill Qualifications Show less



Advanced Biosciences Laboratory

• United States
• Medical Practices
• 1 - 100 Employee

• QC-Supervisor (Microbiology)

  • Feb 2023 - Jul 2023

  Rockville, Maryland, United States -Oversaw the training, performance management, development of 3 direct reports to ensure all testing was executed following cGMP/cGLP/GDP guidelines -Coordinated scheduling of routine/client product microbiological assays to ensure efficiency within the department as well as other departments (Manufacturing, Facilities, Project Management, QA) and third party-vendors -Devised, implemented, and maintained QC programs/procedures to facilitate continuous process improvements… Show more -Oversaw the training, performance management, development of 3 direct reports to ensure all testing was executed following cGMP/cGLP/GDP guidelines -Coordinated scheduling of routine/client product microbiological assays to ensure efficiency within the department as well as other departments (Manufacturing, Facilities, Project Management, QA) and third party-vendors -Devised, implemented, and maintained QC programs/procedures to facilitate continuous process improvements -Worked with Validation to ensure all new/existing laboratory equipment was calibrated and qualified remained in compliance with regulatory guidelines -Authored/oversaw the execution of assay method qualifications -Oversaw on-the-job (OJT) training of new personnel as well as biennial requalifications of existing personnel -Represented QC department in client and regulatory audits (internal as well as external audits of qualified vendors) -Reviewed raw Environmental Monitoring data as well as internal test method data to facilitate release of client drug product -Job roles also encompass all duties listed below for the same employer (QC Analyst III/QC Analyst I)

• QC Analyst III (Microbiology)

  • Apr 2022 - Feb 2023

  Rockville, Maryland, United States -Authored/revised Standard Operating Procedures, Sampling Plans, Test Methods, Material Specifications, and various other controlled documents -Worked directly with clients to create PCAs for sampling, shipping, and testing of final drug products -Led on the job (OJT) training as a Qualified Trainer for new hires/ cross-training of employees -Coordinated with Facilities/Manufacturing to schedule routine maintenance and Environmental Monitoring support for upstream… Show more -Authored/revised Standard Operating Procedures, Sampling Plans, Test Methods, Material Specifications, and various other controlled documents -Worked directly with clients to create PCAs for sampling, shipping, and testing of final drug products -Led on the job (OJT) training as a Qualified Trainer for new hires/ cross-training of employees -Coordinated with Facilities/Manufacturing to schedule routine maintenance and Environmental Monitoring support for upstream, downstream, and final fill operations -Was responsible for the collection, subculturing, and microbial identification of all in-house organism recovery to identify the natural flora of the facility -Tracked and trended organism recovery to qualify and maintain an up-to-date stock of in-house environmental isolates for quality control testing -Led investigations for quality records/compliance events to ensure generation/timely closure of CAPAs/Change Controls/Deviations/EMIs/OOS to meet site Quality Metric goals -Job roles also encompass all duties listed below for the same employer (QC Analyst I)

• QC Analyst I

  • Aug 2021 - Apr 2022

  Rockville, Maryland, United States -Executed sampling/testing of the PW system (TOC/Conductivity/Bioburden) -Performed Static/Dynamic Environmental Monitoring in Grades B-D (Iso 5-8). Experience in Fill/Finish activities and operations in the Grade A BSCs -Executed in-house Growth Promotion/Sterility of all received materials to facilitate the QC release of all media as well as Turbidity/Growth Promotion for Media Fill Qualifications



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Analyst I (Microbiology)

  • Sep 2020 - Aug 2021

  Harmans, Maryland, United States -Qualified in surface, active, air, and non-viable particulate sampling in Grade D (Iso 8)/ Grade C (Iso 7) cGMP cleanrooms as well as Grade A (Iso 5) BSCs. -Analyze microbial counts to verify proper aseptic techniques are upheld and cleanrooms maintain in a state of control and in compliance with ISO 14644 and EudraLex requirements. -Collect WFI samples from ports and test for appearance/color, endotoxin, and bioburden to meet US Pharmacopeia standards. -SME on bioburden testing for… Show more -Qualified in surface, active, air, and non-viable particulate sampling in Grade D (Iso 8)/ Grade C (Iso 7) cGMP cleanrooms as well as Grade A (Iso 5) BSCs. -Analyze microbial counts to verify proper aseptic techniques are upheld and cleanrooms maintain in a state of control and in compliance with ISO 14644 and EudraLex requirements. -Collect WFI samples from ports and test for appearance/color, endotoxin, and bioburden to meet US Pharmacopeia standards. -SME on bioburden testing for WFI/client product. Processed over 1,000 samples submitted in accordance with the site’s 24-hour timeframe with no testing deviations due to analyst error. -Worked with QC compliance to address discrepancies in testing procedures. Helped revise 2 SOPs related to bioburden to ensure quality testing was being upheld. -Participated in EMPQ and Disruption studies. Analyzed data collected based on risk analysis assessment and authored 4 sampling protocols approved by QC and QA departments. -Uploaded data spanning from the 2019 fiscal year to present into an electronic tool to facilitate easy access and retrieval of data. Added new rooms/sampling plans to facilitate site expansion and allow for real-time data trending of our Phase 2 Cleanrooms. -Authored all environmental trend reports for Q4 of the 2020 fiscal year for the site. In total, 7 Q4 and 5 annual trend reports approved by QC Micro, Manufacturing, Facilities, and QA departments. -Qualified/proficient in Sub-culturing/streaking practices and Gram-staining. -Performed a walkthrough of the entire facility to assess current sampling plans/address discrepancies. Using risk analysis assessment/EMPQ data, worked with QC Compliance to revise sampling plans to address QCA/Change Controls and create new SOPS to facilitate expansion. -Assisted in the Implementation of MODA to transition our site from paper-based system to electronic and train the department on the process. -Proficient in writing TrackWise deviations/CAPAs/Change Controls. Show less



LongHorn Steakhouse

• Restaurants
• 700 & Above Employee

• Bartender/ Bar Manager/ Certified Trainer

  • Feb 2014 - Aug 2020

  Wilmington, North Carolina, United States ● Ensured customer satisfaction by delivering a quality product and positive experience through collective teamwork ● Coordinated weekly staff scheduling (direct oversight of 8 individuals). -Utilized adaptive methodology skills to address interdepartmental as well as intradepartmental conflicts in collaboration with employees and management to uphold a functioning, cohesive work environment ● Stocked, maintained records, and completed inventory orders required for sale and… Show more ● Ensured customer satisfaction by delivering a quality product and positive experience through collective teamwork ● Coordinated weekly staff scheduling (direct oversight of 8 individuals). -Utilized adaptive methodology skills to address interdepartmental as well as intradepartmental conflicts in collaboration with employees and management to uphold a functioning, cohesive work environment ● Stocked, maintained records, and completed inventory orders required for sale and distribution per corporate guidelines. -Provided up-to-date records of bar equipment as well as product counts - Completed weekly product inventory and contacted distributors to schedule orders, and monitoring/regulating employee efficiency and reporting any discrepancies - Worked with management to create budgets and implement cost-saving initiatives to maximize allocated resources ● Trained new staff on job requirements (computer skills, interpersonal interactions, OSHA, health standards) and assisted in managerial roles to facilitate optimal performance in a fast-paced working environment ● Financial management of company daily revenue as well as collection and validation of staff profit reports - Generated company reports, addressed employee sales discrepancies, and managed financial deposits ● Upheld an environment in accordance with health regulations to ensure quality control at federal, state, and corporate levels. - Ensured the proper sanitation and sterilization of all equipment before and after use - Ensures the accurate labeling of products of consumption in accordance with FDA standards and guidelines - Adhered to standard measurements, consumption limits, and proper disposal of products in accordance with all Alcohol Law Enforcement North Carolina state regulations as well as FDA regulations - Maintained consistent health scores with public health inspectors as well as private corporate inspectors Show less



EmergeOrtho

• United States
• Medical Practices
• 400 - 500 Employee

• Physician Shadowing- Orthopaedic Trauma Surgery

  • Jan 2018 - Jan 2019

  Wilmington, North Carolina, United States ● Extensive clinical experience and first-hand observation of elective and emergency orthopedic surgeries under supervision of trauma surgeon Neil MacIntyre, III., M.D. ● Familiarization with proper sterilization techniques of medical equipment and environmental factors as well as standard operating procedures ● Witnessed implementation of daily office protocols (patient-doctor interaction, assessment and charting, medical coding)



OAK CREST NURSING CENTER

• United States
• Hospitals and Health Care

• Certified Nursing Assistant

  • Jan 2013 - Jan 2014

  Rockport, Texas, United States ● Provided direct high-quality care to acute rehabilitation and long-term patients in a 92-bed skilled nursing facility ● Assessed/monitored patient vital signs and quality of life to create customized daily care plans ● Charted and organized medical data in compliance with all federal and state regulations and transcribed the information into an electronic database to provide management with daily reports ● Facilitated communication between patients and staff and collaborated… Show more ● Provided direct high-quality care to acute rehabilitation and long-term patients in a 92-bed skilled nursing facility ● Assessed/monitored patient vital signs and quality of life to create customized daily care plans ● Charted and organized medical data in compliance with all federal and state regulations and transcribed the information into an electronic database to provide management with daily reports ● Facilitated communication between patients and staff and collaborated with RNs to correctly address/diagnose problems and efficiently adapt treatment to ensure proper implementation of highest levels of individualized care ● Carried out required duties under minimal to no supervision to assist patients in accordance with stringent state-mandated licensure regulations (feeding, transferring, dressing, maintaining a hygienic environment, etc.) ● Complied with standard precautions outlined by the Center of Disease Control to maintain a work environment in accordance with the Department of Health and Human Services (correct usage of Personal Protective Equipment, proper disposal of Biomedical Waste, accurate documentation of incident reports, infection prevention measures) Show less