Bradley Joseph

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• Indira PenemetchaIndira Penemetcha

  <ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health<ul><li>- Working in Collaboration with the Central Quality team in the development of Quantitative checklists for Aggregate reports.</li><li>- Performing QR of Safety reports i.e, PADER, DSUR, PBRER and DSURs.</li><li>- Managing QR Team for Safety reports and acting as a training lead for Safety Writing Team.</li><li>- Prepared and Performed QC of the trackers for RSI project.</li><li>- Performed Quality review of cases in Argus database for VOQR project. Created error-free reports and other outputs according to tightly defined specifications to ensure timely reporting of assigned job to program management.</li><li>- Participating in weekly meetings on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints</li><li>- Responsible for reviewing the SOPs, job aids as per program specific requirements.</li><li>- Acting as a subject matter expert and helping the team members with day-to-day trouble shooting activities.</li><li>- Signal detection and risk management plan authoring or other assigned PV related activities for client's product(s), per the regulations and SOPs when required.</li><li>- Exhibiting a growing awareness of program strategy and thinking capability alongside independence.</li><li>- Reviewing and providing solutions for issues relating to program delivery or escalating appropriately to the Team Lead / Program Lead as required.</li><li>- Providing standards for gathering information for use in trend analysis.</li><li>- Involved in people development in partnership with PDG leads.</li><li>- Ensuring that all training (internal training and client training) are successfully completed in a timely manner.</li></ul> at Syneos Health

• Jonathan MatulaJonathan Matula

  <ul> <li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li> <li>Department of Agriculture (USDA) and the U.S</li> <li>Department of Homeland Security (DHS)</li> <li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li> <li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li> <li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li> <li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li> <li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li> <li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li> <li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li> <li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li> <li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li> <li>Implemented quality control measures throughout each stage of a project's lifecycle.</li> <li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li> <li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li> <li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li> <li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li> <li>Trained junior staff on best practices for managing multiple projects simultaneously.</li> </ul> at Defense Contracting Activity, LLC<ul> <li>Spearhead the management and oversight of the National Bio and Agro-Defense Facility (NBAF) project, a pivotal national asset developed in partnership with the U.S</li> <li>Department of Agriculture (USDA) and the U.S</li> <li>Department of Homeland Security (DHS)</li> <li>Collaborate with USDA and DHS stakeholders to ensure a seamless transition of operations and mission capabilities from the aging Plum Island Animal Disease Center (PIADC) to NBAF, ensuring uninterrupted research, diagnostics, and training essential to national security</li> <li>Lead the operational endurance phase, validating work processes and laboratory setups to guarantee compliance with the highest safety and biocontainment standards, particularly in biosafety level-4 (BSL-4) environments</li> <li>Act as the hiring manager, conducting interviews and selecting high-quality employees to ensure the success of both DCA and NBAF</li> <li>Serve as a subject matter expert pert for the payroll system Paychex, overseeing and approving payroll for 63 officers biweekly while managing paid time off and leave requests to maintain the security posture for the facility</li> <li>Monitor project milestones, providing critical updates to senior management and stakeholders while ensuring alignment with USDA's mission objectives and federal guidelines</li> <li>Direct the development and execution of strategic initiatives to facilitate efficient collaboration with federal partners, ensuring all laboratory operations adhere to regulatory requirements set forth by the Federal Select Agent Program (FSAP)</li> <li>Foster a culture of excellence and professionalism within the team, emphasizing rigorous training, safety compliance, and operational integrity as key components of NBAF's mission to safeguard public health and the nation's food supply</li> <li>Monitored budgeting activities by tracking expenditures and providing regular updates to management.</li> <li>Analyzed existing processes within a department or organization in order to identify areas for improvement or increased efficiency.</li> <li>Implemented quality control measures throughout each stage of a project's lifecycle.</li> <li>Worked closely with senior managers to ensure that all projects were completed according to schedule.</li> <li>Conducted research on potential vendors, suppliers, contractors and subcontractors for projects.</li> <li>Provided administrative support to the Project Manager in order to facilitate successful project outcomes.</li> <li>Prepared monthly progress reports summarizing key accomplishments achieved since the last report.</li> <li>Trained junior staff on best practices for managing multiple projects simultaneously.</li> </ul> at Defense Contracting Activity, LLC

• Rohit RathorRohit Rathor

  <ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group

• EMEM MEL STUPPARDEMEM MEL STUPPARD

  Construction & Safety Training (Project-Based) at NAConstruction & Safety Training (Project-Based) at NA