Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• Quality Associate

  • Jan 2020 - Sep 2020

  United States * Responsible for receiving and handling (documentation, coordination, investigation, resolution and closeout) of all Clinical Product Quality Complaints for drug products/medical devices/combination products in a manner that complies with regulatory requirements (21CFR Parts 210, 211 and 820). * Created an Excel dashboard with tables and graphs to track workload and due dates of the complaint cases. * Followed up with clinical management for additional details needed for… Show more * Responsible for receiving and handling (documentation, coordination, investigation, resolution and closeout) of all Clinical Product Quality Complaints for drug products/medical devices/combination products in a manner that complies with regulatory requirements (21CFR Parts 210, 211 and 820). * Created an Excel dashboard with tables and graphs to track workload and due dates of the complaint cases. * Followed up with clinical management for additional details needed for complaint investigation and understood the basic elements of the clinical trials. * Followed up with manufacturers to obtain applicable information pertaining to reported product quality complaints, such as sample availability, batch record review, etc. * Used Trackwise to document and categorize the product complaint events. * Performed Trackwise queries to establish a complaint history on the clinical subject, complaint issues and complaint lot numbers. * Monitored product complaints for trends and would notify the manager of events requiring immediate action. * Compiled quality metrics for the manager to help in the preparation of Management reviews and/or other ad hoc reporting requests, such as complaint counts per quarter per complaint issues. * Reconciled product quality related adverse events with Global Pharmacovigilance and provided them a completed investigation report at the time of case closure. Show less



Genpact Pharmalink

• Product Quality Complaints Specialist

  • Jan 2017 - May 2019

  Bridgewater, NJ * Oversee the team under Project Manager’s directives * Author performance metrics and graphs to gain insight into each associate's production level and accuracy. * Compile the results of quality review and provide feedback to the associates on the areas for improvement. * Performing database queries to detect complaint trends and anomaly in the complaint files. * Used Excel to create a dashboard for monitoring current workload as well as case due dates. * Participated in… Show more * Oversee the team under Project Manager’s directives * Author performance metrics and graphs to gain insight into each associate's production level and accuracy. * Compile the results of quality review and provide feedback to the associates on the areas for improvement. * Performing database queries to detect complaint trends and anomaly in the complaint files. * Used Excel to create a dashboard for monitoring current workload as well as case due dates. * Participated in process improvement initiative and pilot testing, which led to the successful rollout of the new process. * Make monthly work assignments for the team. Adjust assignment to accommodate any unscheduled absence and ensure all job functions have appropriate coverage. * Process customer technical complaints on combination products. * Plan and schedule on the job training for the associates and ensure each job function has sufficient number of trained associates. * Monitor current workload and cases close to their due dates. * Provide guidance to team members during complaint case processing, especially for the exceptional scenarios. * interface with various group to resolve any operation issues, such as system administrator, pharmacovigilance and manufacturing sites. * Author corrective actions and preventative actions to address non-conformance and deviations identified. * Prepare and conduct weekly meeting with the client. The weekly meeting involves presenting any issue observed in operation, providing status of the action items and reporting the team’s fulfillment of the service level agreement. * Participate in management discussion on combination product case processing. * Participate in candidate interview and hiring. * Perform HR related tasks, such performance review, disciplinary action, and timesheet approval. Show less



Cognizant

• United States
• IT Services and IT Consulting
• 700 & Above Employee

• Product Quality Complaint Specialist

  • Feb 2015 - Dec 2016

  Bridgewater, NJ * Oversee the team under Project Manager’s directives * Author performance metrics and graphs to gain insight into each associate's production level and accuracy. * Compile the results of quality review and provide feedback to the associates on the areas for improvement. * Performing database queries to detect complaint trends and anomaly in the complaint files. * Used Excel to create a dashboard for monitoring current workload as well as case due dates. * Make monthly work… Show more * Oversee the team under Project Manager’s directives * Author performance metrics and graphs to gain insight into each associate's production level and accuracy. * Compile the results of quality review and provide feedback to the associates on the areas for improvement. * Performing database queries to detect complaint trends and anomaly in the complaint files. * Used Excel to create a dashboard for monitoring current workload as well as case due dates. * Make monthly work assignments for the team. Adjust assignment to accommodate any unscheduled absence and ensure all job functions have appropriate coverage. * Process customer technical complaints on combination products. * Plan and schedule on the job training for the associates and ensure each job function has sufficient number of trained associates. * Monitor current workload and cases close to their due dates. * Provide guidance to team members during complaint case processing, especially for the exceptional scenarios. * interface with various group to resolve any operation issues, such as system administrator, pharmacovigilance and manufacturing sites. * Author corrective actions and preventative actions to address non-conformance and deviations identified. * Prepare and conduct weekly meeting with the client. The weekly meeting involves presenting any issue observed in operation, providing status of the action items and reporting the team’s fulfillment of the service level agreement. * Participate in management discussion on combination product case processing. * Participate in candidate interview and hiring. * Perform HR related tasks, such performance review, disciplinary action, and timesheet approval.

• Product Quality Complaint Analyst

  • Oct 2013 - Jan 2015

  Bridgewater, NJ * Monitor case flow and due dates in case queues. * Adjust work assignments of the team members to accommodate employee absence and to minimize the bottleneck in the case flow. * Familiar with FDA regulations pharmaceutical complaint system and GMP * Promptly triage cases to their respective queues for case processing. * Identify and categorize the product quality issues for the complaint cases received from the call center before sending the cases to the investigation sites. *… Show more * Monitor case flow and due dates in case queues. * Adjust work assignments of the team members to accommodate employee absence and to minimize the bottleneck in the case flow. * Familiar with FDA regulations pharmaceutical complaint system and GMP * Promptly triage cases to their respective queues for case processing. * Identify and categorize the product quality issues for the complaint cases received from the call center before sending the cases to the investigation sites. * Follow up with the consumer or pharmacist for missing complaint detail and process complaint sample retrieval, refund or replacement. * Adhere to HIPPA regulations when complaint intake contains patient's private information. * Assign the case to the appropriate investigation sites and update investigation sites with any new complaint information. * Notify US pharmacovigilance regarding newly identified adverse event. Notify legal department and customer service department for relevant complaint issues or consumer requests. * Perform quality review of the complaint investigation for cases involving adverse events. Send a copy of the closed investigation report to the pharmacovigilance group. * Serve as a liaison with GlaxoSmithKline (GSK), a third party partner, and process customer complaints for the products co-marketed by both companies. * Perform personnel training on triage, case processing and case close out. * Perform quality check on case write up to ensure the completeness and accuracy before a case is entered into the global complaint system (PTC). * Conduct interview of the candidates and ask critical questions to determine whether the candidate is a good fit for both the job and the team.



IGATE

• Information Technology & Services
• 700 & Above Employee

• Product Quality Complaint Analyst

  • Jan 2011 - Sep 2013

  Bridgewater, NJ, USA * Promptly triage cases so that urgent cases can be identified and properly directed. * Identify the product quality issue and appropriately categorize the complaint cases received from the call center before sending the cases to the investigation sites. * Follow up with the consumer or pharmacist for crucial complaint detail and arrange complaint sample retrieval. * Notify US pharmacovigilance regarding newly identified adverse event. Notify legal department and customer service… Show more * Promptly triage cases so that urgent cases can be identified and properly directed. * Identify the product quality issue and appropriately categorize the complaint cases received from the call center before sending the cases to the investigation sites. * Follow up with the consumer or pharmacist for crucial complaint detail and arrange complaint sample retrieval. * Notify US pharmacovigilance regarding newly identified adverse event. Notify legal department and customer service department for relevant complaint issues or consumer requests. * Perform quality review of the complaint investigation to ensure proper and sufficient investigation has been conducted. * Served as a liaison for a third party partner, GlaxoSmithKline (GSK), and process customer complaints for the products manufactured by SANOFI for GSK. * Perform personnel training on case processing. * Perform quality review on the processed cases and communicate the findings to the case processing analysts. Show less



Yoh Scientific Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Project Coordinator

  • Jan 2010 - Jan 2011

  Summit, NJ * Perform TrackWise queries to identify any complaint trend or potential batch non-conformance. * Evaluate product quality complaints filed for US pharmaceutical products and enter complaints into TrackWise database. Assign each complaint with an issue category and a priority before sending the complaint file to the investigation sites. * Coordinate with Merck National Service Center, investigation sites and Global Pharmacovigilance to ensure the complaint cases progress according to the… Show more * Perform TrackWise queries to identify any complaint trend or potential batch non-conformance. * Evaluate product quality complaints filed for US pharmaceutical products and enter complaints into TrackWise database. Assign each complaint with an issue category and a priority before sending the complaint file to the investigation sites. * Coordinate with Merck National Service Center, investigation sites and Global Pharmacovigilance to ensure the complaint cases progress according to the target timeline. * Document the receipt of the customer-returned products and forward the products to the respective investigation sites. * Maintain hard-copy complaint files and make sure that documents are filed into the respective complaint files. * Perform functional tests with Proventil HFA inhalers returned from the customers. Show less



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Complaint Investigation Specialist

  • Dec 2006 - Sep 2009

  Branchburg, NJ * Perform investigation on the customer complaints regarding product defects and documentation/labeling issues and use CRM Clarify software to document the complaint investigation and conclusion. * Perform database searches for previous cases that have a similar complaint issue. * Designed a storage tracking system using Excel and VBA Macro for reagents. * Perform risk analysis for the impact due to a product defect or documentation/labeling error and perform trending analysis for… Show more * Perform investigation on the customer complaints regarding product defects and documentation/labeling issues and use CRM Clarify software to document the complaint investigation and conclusion. * Perform database searches for previous cases that have a similar complaint issue. * Designed a storage tracking system using Excel and VBA Macro for reagents. * Perform risk analysis for the impact due to a product defect or documentation/labeling error and perform trending analysis for the customer reported defects. * Review batch production records and design history files. * Write complaint summary reports detailing the customer's allegation, investigation findings and conclusions. * Interface with various departments, including purchasing, documentation, engineering support and packaging departments for the complaint issues. Notify the Corrective/Preventive Action (CAPA) group of the verified issues and initiate CAPA. * Understand PCR technology applications in Diagnostics including end-point PCR and Real-time PCR. Know the Diagnostics products for HIV-1, HBV, HCV, CT, NG, Quantitative Test, Qualitative Test, Bloodscreening products. * Compliant with FDA regulations on Complaint System. Show less



Adecco

• Switzerland
• Staffing and Recruiting
• 700 & Above Employee

• Complaint Investigation Associate

  • Sep 2004 - Nov 2006

  Branchburg, NJ * Worked as a contractor at the client site, Roche Molecular Systems. * Perform investigation on the customer complaints regarding product defects and documentation/labeling issues and use CRM Clarify software to document the complaint investigation and conclusion. * Perform database searches for previous cases that have a similar complaint issue. * Designed a storage tracking system using Excel and Macro for reagents. * Perform risk analysis for the impact due to a product… Show more * Worked as a contractor at the client site, Roche Molecular Systems. * Perform investigation on the customer complaints regarding product defects and documentation/labeling issues and use CRM Clarify software to document the complaint investigation and conclusion. * Perform database searches for previous cases that have a similar complaint issue. * Designed a storage tracking system using Excel and Macro for reagents. * Perform risk analysis for the impact due to a product defect or documentation/labeling error and perform trending analysis for the customer reported defects. * Review batch production records and design history files. * Write complaint summary reports detailing the customer's allegation, investigation findings and conclusions. * Interface with various departments, including purchasing, documentation, engineering support and packaging departments for the complaint issues. Notify the Corrective/Preventive Action (CAPA) group of the verified issues and initiate CAPA. * Understand PCR technology applications in Diagnostics including end-point PCR and Real-time PCR. Know the Diagnostics products for HIV-1, HBV, HCV, CT, NG, Quantitative Test, Qualitative Test, Bloodscreening products. * Compliant with FDA regulations on Complaint System. Show less



Waksman Institute, Rutgers University

• Lab Technician

  • Feb 2004 - Aug 2004

  * Plant promoter deletion experiments in search for the functional areas of the promoter for KAN1 transcription factor. * Transform Arabidopsis with agrobacteria that carry partially deleted promotors. * Transform plants with agrobacteria and maintain the transformed plants.