James Patrick Email & Phone Number

Philadelphia, Pennsylvania, United States

Lansdale, Pennsylvania, United States

Wayne, Pennsylvania, United States

• Responsible for creating and leading training for new hire orientation, LAUNCH and sitewide training on technical subjects.
• Aided in the creation and implementation of the LAUNCH technician onboarding program.
• Created and lead training programs on Root Cause Analysis, TrackWise deviation management system, deviations/laboratory investigations, LIMS new hire and lab technician training programs.
• Created a training document management system using VBA and Microsoft applications.
• Participated in computer systems validation activities to support the introduction of a new LMS.
• Created training videos on assorted topics using Camtasia.

United States

• Assisted in and led new hire orientation training for new hires.
• Led quarterly technical systems training (online).
• Took on training document maintenance and archive responsibilities.
• Partnered with QA to design Root Cause Analysis (RCA) training.
• Conducted deviation investigations within the scope of the training department.

• Investigated production related deviations and complaints.
• Drafted and revised production related SOPs
• Initiated, implemented, and managed production CAPA plans.
• Initiated and managed production change requests.
• Worked with Quality Assurance to improve a change request action tracker.

Greater Philadelphia Area

• Returned to NCE investigations to support business need. Continued to act as Administrator for the Quality Assurance Tracking System.
• Recognized for my assistance with Quality Assurance process improvements.
• Developed methods and tools for extracting data from PDFs and legacy systems for analysis.
• Designed and developed MS Excel based investigation tools to improve investigation workflow.
• Member of the logbook task force, an interdepartmental group focused on improving logbook issuance, review, and reconciliation.

Philadelphia, Pennsylvania

• Review Manufacturing Standard Operating Procedures (SOP) for documentation and compliance errors.
• Work with subject matter experts to ensure SOPs are accurate and complete.
• Draft SOPs for Manufacturing. Assist with NCE investigations as required.
• Volunteered to be the administrator for the Quality Assurance Tracking System, a MS Access based database used to track documentation, Right First Time (RFT) metrics, and other data for the Quality Assurance groups.
• Designed a SOP analysis tool to determine the overall effectiveness of the procedure.
• Assisted with the design of Root Cause Analysis (RCA) training for company wide use.

Greater Philadelphia Area

• Generate compliance reports for Manufacturing and Quality Assurance Management.
• Perform trend and data analysis in addition to Technical Operations Specialist responsibilities.
• Designed drafting templates and tools used for investigations.

Greater Philadelphia Area

• Investigate Non-Conforming Events (NCEs) within the scope of Manufacturing, including environmental monitoring excursions. Investigation techniques include gathering data from facility monitoring systems (REES) and.
• Performing GEMBA inspections of the Manufacturing areas and outside research.
• Assess the impact of NCEs on GMP product and quality systems.
• Work with Manufacturing and Quality Assurance to ensure product impact and disposition is documented and instructions implemented.
• Use Root Cause Analysis (RCA) techniques to assess the root cause of NCEs. RCA techniques include the use of fish bone diagrams, change analysis, process flow and logic trees and "7 M's".
• Document the NCE investigation for Manufacturing, Quality Assurance, and client review.

• Perform daily clean room operations as an Operator and Verifier. Duties Include use of Oracle database to record and verify key steps in processing, Aseptic technique in manipulations within a Biosafety Cabinet.
• Measurement and inspection of raw materials used during processing.
• Proper Aseptic Gowning, and proper use of Personal Protective Equipment.
• Train new and current employees, Initiate and Investigate Exception Reports, Review Batch Records.
• Receive raw material for further processing and packaging of the final product.

Morris Plains, NJ

• Perform daily cleanroom operations as Operator and Verifier. Duties Include use of Oracle database to record and verify key steps in processing, Aseptic technique in manipulations within a Biosafety Cabinet, maintain.
• Measurement and inspection of raw materials used during processing. Proper Aseptic Gowning and proper use of Personal Protective Equipment. Other duties include Batch Record Review and assisting management with other.

Hillsborough, NJ

Job duties include fill line inspection, preparing lot samples for long term storage, auditing of aluminum vendor, product defect cataloging and daily logging, safe disposal of expired and old regents and retain samples and cataloging of lot samples.

Flemington, NJ

Cut core steel to proper specifications for ferrite core transformers, prepared the ferrite cores to proper specification for use in transformers, stocked raw steel for use in production using a forklift and fork truck, minor repair and daily maintenance of high speed steel cutting machine.

Wired Biomanufacturing Certification, Biology Technician/Biotechnology Laboratory Technician

Wired program includes: Aseptic Technique, Mammalian Cell Culture, Gel Electrophoresis, PCR, Gas Spectrometry, and FDA regulatory affairs.

Education record