Summary
Overview
Work History
Education
Skills
Timeline
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Tony Jenkins

Raleigh,NC

Summary

Accomplished Deviation Investigator with a proven track record at Biogen, adept in Monitoring and Evaluation and fostering team productivity. Excelled in establishing CAPA plans with a 90% on-time closure rate for high-priority deliverables, demonstrating exceptional investigation management and mentorship abilities. With direct laboratory experience in testing and analysis across metabolic syndrome, molecular oncology, toxicology, molecular and gene therapies.

Overview

6
6
years of professional experience

Work History

Deviation Investigator

Biogen
08.2022 - Current
  • Perform site monitoring to evaluate conformance and application of Good Clinical Practices (GCP) in Bio Site manufacturing areas and warehouses.
  • Evaluate the quality and integrity of production sites' practices related to the conduct of production protocols and conformance to applicable regulations.
  • Determine root causes and establish Corrective and prevention Action (CAPA) plans for staff.
  • Administer protocol and related study trainings for staff resulting in 95% RFT on Area Manager and Quality Control approval.
  • Collaborate with staff to maintain appropriate documentation for CAPAs, conducted trainings, and enhanced alignment with all project related protocols resulting in 90% on time closure rate on high priority deliverables.
  • Established regular lines of communication with staff and leadership to manage ongoing project expectations and issues, provide quality governance updates, and escalate quality issues when appropriate.
  • Support upper management to identify opportunities to drive, and track staff recruitment plans to fill necessary skills related gaps and enhance productivity.

Senior Analyst

Novartis Gene Therapies
05.2020 - 07.2022
  • Mentored junior analysts, fostering professional development while enhancing overall team performance.
  • Collaborated with cross-functional teams to identify areas of improvement, leading to increased operational effectiveness.
  • Improved company efficiency with the development of key performance indicators and tracking metrics.
  • Provided expert advice for senior management, contributing to informed decision-making and strategic planning.
  • Served as investigation SME and team member supporting quality events pertaining to testing procedures and process protocols.
  • Generated Standard operating procedures for the management of site documentation to ensure trainings, workplans, procedures, process protocols and outcomes were maintained in accordance with GCP and other regulatory requirements.

Molecular Oncology Technologist

Laboratory Corporation of America
05.2018 - 05.2020
  • Mentored junior team members to enhance their technical skills and improve overall team productivity.
  • Managed the progress of assigned studies and clinical trials by effectively bridging studies, tracking regulatory submissions and approvals.
  • Applied GCP's in the processing and quality control of new reagents and analysis controls.
  • Applied GCP's while performing various tests and analyses according to established testing procedures.


Education

Bachelor of Arts - Biology

University of North Carolina At Greensboro
Greensboro, NC

Skills

Monitoring and Evaluation

Results based Accountability

Research abilities

Metabolic trials

Risk Assessment

Investigation Management

Timeline

Deviation Investigator

Biogen
08.2022 - Current

Senior Analyst

Novartis Gene Therapies
05.2020 - 07.2022

Molecular Oncology Technologist

Laboratory Corporation of America
05.2018 - 05.2020

Bachelor of Arts - Biology

University of North Carolina At Greensboro

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Tony Jenkins