James Duana
Summary
Experienced professional with many years of demonstrated history of working in the medical device and pharmaceutical industry. Skilled in deviation Writing, internal audits, batch record review, GMP investigation, quality assurance, document management, supervision, Microsoft office, and project management, to list a few.
Overview
6
6
years of professional experience
Work History
Scientist III GMP Investigation Specialist
Eurofins Lancaster Laboratories
05.2022 - Current
- Analyze and evaluate information captured through investigations and summarize information and trends in investigation reports.
- Prepare investigation reports that include recommendations on investigation findings for medium/high severity nonconformances.
- Perform several root-cause and problem-solving tasks to determine the root cause for investigation and to identify effective corrective and preventative action.
- Review completed batch records and logbooks in accordance with cGMP standards to support investigations.
Sr. Quality Assurance Technician
Catalent Pharma Solutions
07.2021 - 05.2022
- Identify, investigate, and solve quality issues during aseptic formulation and filling using CAPA (Corrective Action Preventive Action).
- Communicate with other department leaders to record and resolve deviations/nonconformances using Track Wise software.
- Inspect incoming manufacturing products and component parts for quality standard compliance to ensure that quality issues concerning production are effectively addressed.
- Initiate work orders for QA hold tags using Maximo (enterprise asset management software) for decommissioned manufacturing equipment.
- Ensure successful completion of key quality projects according to client needs by following standard operating procedures (SOPs).
- Issue batch records and other documents for manufacturing purposes.
- Supervise the installment of aseptic pathway for drug product formulation and filling.
- Oversight manufacturing of products on the floor during manufacturing operations.
- Conduct monthly audits in the manufacturing areas to ensure proper procedures are followed according to CGMP (Current Good Manufacturing).
Test Evaluator/Test Scorer - (Remote Contract)
BCforward
04.2021 - 06.2021
- Assess Standardized tests administered to elementary through high school students
- Evaluate students’ responses remotely to subject-related open-ended questions according to DRC supplied scoring guide.
- Secure testing materials to maintain confidentiality and Integrity.
Wellness Clerk
Cook Medical Incorporated
05.2019 - 08.2019
- Create and deliver presentations to inform employees of opportunities with the new Employee Assistance Program during lunch and learn sessions bimonthly at the Bloomington branch and monthly delivery to external branches ranging from Indiana to North Carolina.
- Dissemination of information to employees regarding health awareness month topics such as Alzheimer’s and Breast Cancer Awareness month by creating flyers and posters.
- Responsible for managing inventory, supply orders, and accounting for deliveries.
- Plan and prepare meals to encourage participation in lunch and learn sessions.
Informal Sport Supervisor
Indiana University-Bloomington
08.2018 - 05.2019
- Supervise over 200,000 square feet of space and thousands of participants, and provided customer service to facilitate a safe and enjoyable environment for the gym facility.
- Collaborate with coworkers to ensure daily policies and protocols are in place and followed regularly by participants.
Quality Control Operator/Inspector (Seasonal)
Cook Medical Incorporated
05.2015 - 08.2018
- Inspect various medical products to ensure quality standards are met before distribution.
- Coordinate communication between departments to relay quality issues with products according to company standards.
- Construct medical devices following detailed instruction manuals to ensure efficiency and quality.
- Responsible for producing a quality product in a timely manner.
- Document inspection results by completing reports and logs.
Education
Healthcare - Management & Policy
Bachelor of Science - Healthcare Management & Policy
Indiana University Bloomington
Bloomington, IN12.2020
Skills
- Quality Assurance Auditing
- Problem-solving
- Quality Control
- Batch Record Review
- Deviation Writing
- CGMP (Current Good Manufacturing Practices)
- TrackWise Software
- Document Management
- Client Services
- CAPA (Corrective Action and Preventive Action)
- MES (Manufacturing Execution Systems)
- Microsoft Office
- SOPs (Standard Operating Procedures)
- Inventory Management
- Critical Thinking
- ISO 13485
- ISO 9001
- QMS (Quality Management System)
- EDMS (Electronic Document Management System)
- EU MDR (European Union Medical Device Regulation)
- RCA (Root Cause Analysis)
- LIMS (Laboratory Information Management System)
Timeline
Scientist III GMP Investigation Specialist
Eurofins Lancaster Laboratories
05.2022 - Current
Sr. Quality Assurance Technician
Catalent Pharma Solutions
07.2021 - 05.2022
Test Evaluator/Test Scorer - (Remote Contract)
BCforward
04.2021 - 06.2021
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
Healthcare - Management & Policy
Bachelor of Science - Healthcare Management & Policy
Indiana University Bloomington