Krupali J. Email & Phone Number

Irvine, California, United States

Partner with the Engineering teams to create and review Change Orders and facilitate CO Arena workflows successfully through the system. DMR Training Coordinator, responsible for managing the assignment, completion, and record retention of all On the Job (OJT) training for new and revised production procedures and Device History Record travelers required for manufacturing personnel. Support three key aspects of the quality system: Change Administration, Training Management, and Supplier Management with focus on supplier audits. Arena Change Administrator, facilitating activities associated with implementing and sustaining Arena PLM as the configuration management system of record for parts, assemblies and BOMs as well as the electronic QMS for documents, records, training, supplier management, control of nonconforming product, and other select elements of the QMS including supplier monitoring of incoming materials. Support Quality System activities associated with establishing and implementing an ISO 13485:2016 and EU MDR 2017/745 compliant quality management system.

Tampa, Florida, United States

Maintain supplier quality oversight of ongoing production of dietary supplements, drug products, and controlled substance pharmaceuticals produced at CMO/CPOs. Monitor, maintain, manage, develop (when applicable), and review product quality assurance processes (i.e. deviations, product complaints, change controls, product holds, batch release)for Trigen Laboratories product portfolio in collaboration with Osmotica Pharmaceuticals Quality Management and Quality Assurance teams at CMO/CPOs. Disposition finished goods for commercial distribution at Trigen Laboratories distribution locations. Draft, update, and review Supplier Corrective Action Reports. Investigate and complete closure of Product Complaints. Data gathering, maintenance, and mining applicable Quality Assurance Metrics for continuous improvement. Participate in quality process improvement activities, keeping continuous improvement in mind.

Tampa/St. Petersburg, Florida Area

Responsible for supporting Trigen and contract manufacturing and packaging organizations (CMO, CPO) activities in order to meet cGMPs (21 CFR 111 and 211), quality specifications and company goals. Perform day to day technical activities supporting CMO/CPO for dietary supplements and drug product manufacturing, i.e. review and approval of documentation (batch manufacturing record and/or packaging, deviation, investigation, etc.), process changes, trouble shooting and improvements. Utilize a robust understanding of applicable regulations, standards, and applicable company policies and procedures to ensure compliance. Perform quality related activities of diverse scope, make decisions and implement those actions in partnership with other departments.

Jacksonville, Florida

Responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. Utilized and applied knowledge of quality systems and approaches. Maintained and applied an understanding of the relevant regulations, standards and operating procedures. Performed investigations / root cause analysis and developed corrective actions. Performed gap assessments to specified requirements. Utilized quality concepts such as: cost of quality, analytical metrics and statistics, trending, quality planning, validation, CAPA and problem solving. Worked cross-functionally and interpreted the requirements as well as educated and influenced others on those requirements. Department Head of SPP team. Spearheaded QRA department metrics reporting by way of innovative Tableau Dashboards. Acted as Quality Assurance management providing oversight, support, and lead continuous improvement initiatives to assist facility in maintaining compliance to Cardinal Health Quality Policies/Procedures and cGMPs at Jacksonville, FL Cardinal Health At-Home distribution center. Acted as designated QA management support and representative for on-site regulatory and corporate internal audits at Jacksonville, FL Cardinal Health and Jacksonville, FL Cardinal Health At-Home distribution centers.

Wabash, Indiana

Provide quality oversight to the cGMP production of Dietary Supplements (DS). Primary hands on production support for Quality Assurance Management at Living Essentials. Help ensure compliance to SOPs, Work Instructions, batch records, master manufacturing record, and/or to 21 CFR Part 111 on the production floor. One of the first points of contact for quality related production issues for operations supervision and the primary liaison for the Quality manager on production matters. Oversee and maintain HACCP/Food Safety plan and team. Own and extrapolate Internal Auditing system. Backroom support for external 3rd party and regulatory audits. Sub system admin for electronic document control system MasterControl.

Anderson, Indiana

Performed quality control tests/inspections and/or standard microbiological testing and assays on products, materials, components, etc. at various stages of the production process to ensure compliance with quality and reliability standards. Managed finished goods positive release, net contents and the sensory program. Maintained meticulous records of statistical data. Analyzed said data and wrote summaries to validate or show deviations from existing standards. Recommended modifications to existing, or suggest new, standards, methods and procedures. Worked closely with the Quality Management Team to help identify, solve and prevent problems affecting quality. Followed and carried out company Quality Policy on all required/applicable Good Manufacturing Practices (GMPs), quality and food safety requirements. Escalated quality or food safety findings or incidents to management. Ensured high quality of products, services, housekeeping, and hygiene standards were maintained and improved in designated areas. Ensured the compliance for FSSC 22000 and ISO 9001 while driving continuous improvement for Quality metrics/Key Performance Indicators (KPI) in the Microbiology Laboratory area. Supported Lean Manufacturing Improvement initiatives with the factory management team and manufacturing/packaging personnel. Assisted, advised and trained Production Operators in attaining Nestlé quality standards. Responsible for reviewing and updating factory policies and standard operating procedures (SOPs) in compliance to Nestle standards. Supported Compliance by ensuring effective use of the factory’s document control program. Entered SAP lot summary reports for compliance to the Quality Monitoring Scheme (QMS). Supported production in decisions related to quality and food safety. Audited GMPs, procedures and paperwork on the production floor. Conducted coaching and training to employees. Executed routine review of the Hazard Analysis Critical Control Point (HACCP) documentation.

Dublin, Oh

Performed and documented routine tasks related to sample processing and assays using written operating procedures, standard laboratory methods, and basic laboratory techniques, functions and equipment. Conducted specific procedures and tests within the laboratory requiring the use of applied knowledge and practical skills learned from on-the-job experience. Modified or adapted laboratory techniques to fit special needs or problems. Calculated data from routine tests to final results and to evaluate such results for accuracy where expected findings are not precisely defined, but sufficient guidelines exist for reference. Assisted with and occasionally performed specialized and non-routine tests and assays, and maintained records of such work. Coordinated and planned assigned work with other technicians and scientists. Registered and prepared samples for general analytical testing through data entry, weighing and physical homogenization. Prepared and performed routine to more complex analyses per NQAC methods. Read and recorded results of analyses, making sure to keep identification numbers matched with correct samples. Operated basic laboratory equipment such as balances, pH meter, autoclave, etc. Prepared (and assured accuracy of) standards, reagents, etc. needed for analyses. Functioned as primary data generator, records and calculated data. Performed routine lab and department maintenance to keep area clean and orderly. Conducted preliminary interpretations of data/observations, and drafted short reports to supervisor. Assured quality of results by assisting with establishment and maintenance of QA documents, plans and ICPs. Documented QA data and reported to lead or lab management.Assured equipment was maintained in reliable working order and made repairs or modifications within personal capability. Participated/lead Lean Laboratory initiatives. Assisted in write-ups, reviews, and provided proper documentation for processes and methods.

Dublin, Ohio

Assisted in the sensory science sector of the research and development department. Prepared and served food for sensory evaluation under instruction of R&D personnel. Maintained sense of urgency and detailed orientation with regard to all assigned tasks as directed. Required the ability to prioritize multiple competing tasks to set-up and complete sensory testing on Wendy’s products. Maintained fast pace required for all sensory panels. Rapidly assimilated and utilized new information for adaptation to new situations and procedures. Produced a consistent product throughout the entire duration of a panel to ensure highest level of accuracy.

Bachelors Of Science In Food Science, Food Science And Technology

Supplemental Education Courses

General Education Courses (Kap Classes), General Chemistry, English Composition, And Elementary Classroom Spanish Courses