James Duana
Bloomington,IN
Summary
Reliable, passionate, and well-mannered GMP Investigation Specialist - Consultant with over 6 years of experience in the medical/pharmaceutical industry resolving quality issues and client complaints through advanced technology and cross-functioning team discussion. Ability to address client complaints or concerns in a timely manner. Expertise in client services, batch record review, deviation investigation/writing, and quality assurance.
Overview
8
8
years of professional experience
Work History
Scientist III GMP Investigation Specialist-Remote
Eurofins Lancaster Laboratories
Rensselear, NY
05.2022 - Current
- Analyze and evaluate information gathered during investigations, as well as summarize data and trends in investigation reports.
- Facilitate daily cross-functional meetings to plan and coordinate deviation closure plans.
- Prepare investigation reports that include recommendations based on investigation findings for nonconformances of medium/high severity.
- Perform daily root-cause and problem-solving tasks in order to identify the root cause for investigation and recommend effective corrective and preventative action.
- Review hundreds of completed batch records and logbooks in accordance with cGMP standards to support manufacturing investigations.
Sr. Quality Assurance Technician
Catalent Pharma Solutions
Bloomington, IN
07.2021 - 05.2022
- Initiate work orders for QA hold tags for decommissioned manufacturing equipment using Maximo (enterprise asset management software).
- Write daily deviation reports and manage confidential quality assurance documents with TrackWise software.
- Inspect incoming manufacturing lots and component parts for quality standard compliance to ensure that quality issues concerning production are effectively addressed.
- Issue batch records and other documents for manufacturing purposes.
- Review deviations, corrective and preventive actions, vendor assessments, risk assessments, and non-conforming material reports.
- Ensure the successful completion of key quality projects in accordance with client requirements by adhering to standard operating procedures (SOPs).
- Supervise the installation of an aseptic pathways for the formulation and filling of manufacturing drug products.
- Oversight of manufacturing of drug products on the floor during manufacturing operations.
- Perform hundreds of manufacturing batch review.
- Conduct monthly audits in manufacturing areas to ensure proper CGMP (Current Good Manufacturing Practice) procedures are followed.
Quality Control Operator/Inspector (Seasonal)
Cook Medical Incorporated
Bloomington, IN
05.2015 - 08.2018
- Construct hundreds of medical devices following detailed instruction manuals to ensure efficiency and quality.
- Inspect hundreds of medical device products to ensure quality standards are met before distribution.
- Determine the quality or compliance risks connected to a manufactured lot, communicate those risks, and coordinate a risk management strategy.
- Coordinate hundreds of communication between departments to relay quality issues with products in accordance with company standards and Food and Drug Administration (FDA) requirements.
- Deliver hundreds of finished products in a timely manner.
- Document inspection results by completing reports and logs.
Test Evaluator/Test Scorer - (Seasonal Contract)
BCforward
Indianapolis, IN
04.2021 - 05.2023
- Examine standardized tests given to students in elementary, middle, and high school.
- Evaluate and score hundreds of students' test responses to subject-related open-ended questions using the scoring guide provided by Data Recognition Corporation (DRC).
- Secure testing materials to maintain their confidentiality and integrity.
Wellness Clerk
Cook Medical Incorporated
Bloomignton, IN
05.2019 - 08.2019
- Create and deliver biweekly presentations to inform employees about the new Employee Assistance Program (EAP) opportunities during bimonthly lunch and learn sessions at the Bloomington branch and monthly delivery to external branches ranging from Indiana to North Carolina.
- Create flyers and posters to distribute information to employees about health awareness month topics such as Alzheimer's and Breast Cancer Awareness month.
- Manage inventory, place orders, and track deliveries.
- Plan and prepare meals to encourage lunch and learn session participation.
- Take minutes during biweekly presentation to employees.
Informal Sport Supervisor
Indiana University-Bloomington
08.2018 - 05.2019
- Supervise over 200,000 square feet of space and thousands of participants, as well as provide customer service to ensure the gym facility's safety and enjoyment.
- Collaborate with coworkers to ensure that daily policies and protocols are in place and that participants follow them on a regular basis.
Education
Bachelor of Science - Healthcare Management & Policy
Indiana University-Bloomington
Bloomington, IN12.2020
Skills
- Deviation Writing
- Batch Record Review
- Quality Assurance Auditing
- Quality Control
- Floor Support
- Client Services
- CGMP (Current Good Manufacturing Practices)
- TrackWise Software
- QMS documentation
- Change control
- CAPA (Corrective Action and Preventive Action)
- MES (Manufacturing Execution Systems)
- SOPs (Standard Operating Procedures)
- ISO 9001/ISO 13485
- Laboratory Information Management System (LIMS)
- Design Control
- Oracle
- Inventory Management
- Microsoft Office
Websites
Timeline
Scientist III GMP Investigation Specialist-Remote
Eurofins Lancaster Laboratories
05.2022 - Current
Sr. Quality Assurance Technician
Catalent Pharma Solutions
07.2021 - 05.2022
Test Evaluator/Test Scorer - (Seasonal Contract)
BCforward
04.2021 - 05.2023
Wellness Clerk
Cook Medical Incorporated
05.2019 - 08.2019
Informal Sport Supervisor
Indiana University-Bloomington
08.2018 - 05.2019
Quality Control Operator/Inspector (Seasonal)
Cook Medical Incorporated
05.2015 - 08.2018
Bachelor of Science - Healthcare Management & Policy
Indiana University-Bloomington
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