Anthony J. Kuznetsov Email & Phone Number

Bloomington, In, Us

Bloomington, Indiana, United States

As a dedicated Change Control Coordinator, I oversee pivotal aspects of change management within our organization, ensuring seamless transitions and adherence to quality standards. Here's a glimpse into my responsibilities:Change Control Coordination:• Facilitate Change Control Board (CCB) meetings, ensuring timely scheduling and comprehensive agenda preparation.• Maintain meticulous records of CCB meetings, documenting decisions and follow-up actions to uphold process… Show more As a dedicated Change Control Coordinator, I oversee pivotal aspects of change management within our organization, ensuring seamless transitions and adherence to quality standards. Here's a glimpse into my responsibilities:Change Control Coordination:• Facilitate Change Control Board (CCB) meetings, ensuring timely scheduling and comprehensive agenda preparation.• Maintain meticulous records of CCB meetings, documenting decisions and follow-up actions to uphold process accountability.• Efficiently process change control requests from various departments, ensuring uniform submission formats and transparency.Change Control Reviews:• Conduct thorough reviews of Change Controls in TrackWise, ensuring adherence to SOPs and organizational standards.• Provide detailed feedback to authors for necessary corrections, promoting accuracy and completeness in submissions.Client Communication and Approval Processing:• Act as a liaison with clients regarding change control requests, addressing inquiries and facilitating approval processes.• Ensure timely processing of client approvals, enabling smooth implementation of changes within set timelines.Training and Compliance:• Stay updated on change management processes and regulatory requirements, participating in training sessions to enhance skills.• Ensure compliance with regulatory standards and organizational policies in all change control activities.Process Improvement and Collaboration:• Identify opportunities for process improvements and collaborate with cross-functional teams to enhance change management practices.• Provide guidance and support to colleagues on change control procedures and best practices.Additionally, as a valued member of the QA-PMF team, I review and approve preventive maintenance work orders, ensuring adherence to quality standards and fostering a culture of excellence within the team. Show less

Bloomington, Indiana, United States

As a QA Representative with a specialization in Floor Support, I played a pivotal role in upholding the highest quality and compliance standards in the pharmaceutical manufacturing field. My key responsibilities included:• Conducted Acceptance Quality Limit (AQL) inspections on products evaluated by MVI and AIM, ensuring that labeled and packaged finished products processed through High-Speed Packaging equipment (Dividella) and Serialization equipment meet stringent quality… Show more As a QA Representative with a specialization in Floor Support, I played a pivotal role in upholding the highest quality and compliance standards in the pharmaceutical manufacturing field. My key responsibilities included:• Conducted Acceptance Quality Limit (AQL) inspections on products evaluated by MVI and AIM, ensuring that labeled and packaged finished products processed through High-Speed Packaging equipment (Dividella) and Serialization equipment meet stringent quality standards.• Provided real-time support and oversight during Parenteral Inspection, Labeling, and Packaging operations, with a focus on maintaining compliance with Good Manufacturing Practices (GMP) through batch record reviews.• Reviewed and approved change requests for Standard Operating Procedures (SOPs) and other GMP documents within the Electronic Document Management System (EDMS).• Utilized JD Edwards for efficient product traceability management, including the placement and removal of products from hold or reject status, optimizing workflow.• Effectively managed work orders in IBM Maximo, ensuring precise handling of QA hold tags. This involved placing equipment on hold to prevent its use until validated or GMP-ready, contributing to enhanced operational efficiency.• Experienced participating in triage meetings, where the severity levels to deviations were assigned. Additionally, I have a background in initiating deviations and authoring a minor deviation in the Global TrackWise system to facilitate timely issue resolution.• Conducted regular area clearances and Quality Assurance audits in Secondary manufacturing rooms to uphold a controlled and compliant working environment, adhering to regulatory standards.• Played a role in expediting the validation of inspection and packaging machinery in a startup building by assisting in the review of commissioning documents, including Installation Qualification (IQ) and Operational Qualification (OQ) protocols. Show less

Bloomington, Indiana, United States

• Performed meticulous QC microbiological testing, encompassing bioburden and endotoxin assessments, across stability, raw materials, in-process materials, and final product samples. Recorded results with precision in LIMS.• Executed testing with aseptic technique in Laminar Flow Hoods, maintaining a sterile environment to ensure the accuracy of microbiological analyses.• Experienced in method validation, specifically in bioburden suitability testing of test procedures. Initiated change… Show more • Performed meticulous QC microbiological testing, encompassing bioburden and endotoxin assessments, across stability, raw materials, in-process materials, and final product samples. Recorded results with precision in LIMS.• Executed testing with aseptic technique in Laminar Flow Hoods, maintaining a sterile environment to ensure the accuracy of microbiological analyses.• Experienced in method validation, specifically in bioburden suitability testing of test procedures. Initiated change requests for the corresponding test procedures within the EDMS to enhance procedural effectiveness.• Operated in a GMP environment, acquiring comprehensive knowledge of CGMP Documentation Practices. Consistently reported test results on Master Batch Records (MBRs), contributing to the overall quality and compliance of manufacturing processes.• Facilitated the training and evaluation of fellow teammates across all shifts in bioburden testing techniques, ensuring a consistent and high standard of performance.• Engaged in the review and interpretation of bioburden plates, meticulously inspecting TSA plates to identify bacterial growth and uphold the integrity of microbiological data. Show less

Bloomington, Indiana, United States

• Supported the QC laboratories by picking up and delivering samples for testing, conducted sample searches, maintained lab spaces in a clean, organized, and stocked condition, and assisted with the autoclaving of buffers/media.• Conducted critical chemical analyses of in-process and final product samples, including on-demand samples, with integrity, focusing on pH testing, osmolarity, and dosimetry. Adhered to safety procedures and written instructions, reporting results meticulously on… Show more • Supported the QC laboratories by picking up and delivering samples for testing, conducted sample searches, maintained lab spaces in a clean, organized, and stocked condition, and assisted with the autoclaving of buffers/media.• Conducted critical chemical analyses of in-process and final product samples, including on-demand samples, with integrity, focusing on pH testing, osmolarity, and dosimetry. Adhered to safety procedures and written instructions, reporting results meticulously on worksheets and in LIMS in a timely and appropriate manner.• Operated and calibrated a variety of laboratory instruments, such as Density Meters (for Volume testing), pH Meters, Osmometers, and Dosimetry systems.• Peer-reviewed analytical tests, including Delivery Volume, Breakaway (BreakForce) and Trigger Force, Dosimetry, pH, and Osmolality measurements.• Maintained data integrity and ensured compliance with company SOPs and specifications.• Contributed to functional team efforts, impacting production, enhancing efficiency, and solving problems, thereby generating cost savings and improving overall quality. Show less

Bloomington, Indiana, United States

• In Dr. Dean Rowe-Magnus's lab, I contributed to research focused on characterizing the Super Integrons of the Vibrionaceae. Employing a multifaceted approach encompassing sequencing, in vitro biochemical analysis, in vivo genetic manipulation, and DNA array and expression analysis, I played a role in unraveling the intricate details of these genetic elements. My specific focus involved investigating the role of putative hormone receptors encoded in the genome of the opportunistic human… Show more • In Dr. Dean Rowe-Magnus's lab, I contributed to research focused on characterizing the Super Integrons of the Vibrionaceae. Employing a multifaceted approach encompassing sequencing, in vitro biochemical analysis, in vivo genetic manipulation, and DNA array and expression analysis, I played a role in unraveling the intricate details of these genetic elements. My specific focus involved investigating the role of putative hormone receptors encoded in the genome of the opportunistic human pathogen Vibrio vulnificus, shedding light on their influence in regulating bacterial physiology during infection. Show less

Bachelor Of Science - Bs, Microbiology, General

Activities and Societies: Dean's List (min. GPA of 3.7), Sigma Alpha Pi Honor Society (min. GPA of 3.5)

High School Diploma

Activities and Societies: National Society of High School Scholars (min. GPA 3.5), National Junior Honor Society