Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Kelomi Swint

Philadelphia,PA

Summary

Focused Project Manager adept at planning, directing and maintaining continuous operations in various departments. Experienced in directing manufacturing employees and keeping efficient production in accordance with quality standards. Applying creative and analytical approach to operations for continuous process improvement. Skilled at identifying or anticipating problems and providing solutions. Excels through mentoring, training and empowering team to excel in performance.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Project Manager

Catalant
12.2021 - 06.2024
  • Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
  • Planned, designed, and scheduled phases for large projects.
  • Met project deadlines without sacrificing build quality or workplace safety.
  • Established effective communication among team members for enhanced collaboration and successful project completion.
  • Delivered exceptional customer satisfaction by proactively addressing client concerns and meeting or exceeding expectations throughout engagement process.
  • Created accurate budgets based on resource requirements, allowing for optimal allocation of funds across all aspects of projects.

Project Manager

Clinigen
12.2020 - 11.2021
  • Under own direction for assigned projects or in support of a project management team coordinate projects from award stage to completion ensuring correct planning timelines are generated, monitored and tracked to ensure successful adherence and completion
  • Attend and produce minutes and actions for client meetings/teleconferences/client visits and Audits to support own assigned projects or project management team and understand full scope requirements to generate all required project documentation
  • Receive, monitor and manage client supplied label text/randomizations, drug, components and materials and ensure delivery to internal functions as required
  • Generate required documentation and liaise with depot group for 3rd party depot set up
  • Manage inventory reporting and monitor and track client inventory in line with project requirements
  • Set up clients on fusion suite as required, provide ongoing support for client use and password management
  • Accurately Forecast M&P revenue, project management revenue, and supply chain to support S&OP and site forecast process

Quality Assurance Documentation Specialist

Clinigen
05.2020 - 12.2020
  • Oversaw incoming inspection, disposition and life cycle for all clinical supplies.
  • Responsible for the inspection, disposition and maintenance of Clinical Trial Labels.
  • Perform in-process inspections ensuring materials are produced according to quality standards and established quality systems.
  • Collaborated with management to provide training on improved processes and assist with creation and maintenance of quality training.
  • Participated in change management initiatives related to documentation updates, facilitating smooth transitions between old and new procedures.
  • Improved documentation accuracy by conducting thorough quality reviews and implementing necessary revisions.

Quality Assurance

Almac Clinical Technologies
08.2018 - 05.2020
  • Performed the role as document controller in management of GxP documentations and to assist in customer audits.
  • Performed Quality Assurance (QA) functions in reviewing GxP documentation in accordance with the principles of GxP and internal SOPs
  • Examine and authorize all batch records before production to confirm their compliance with cGMP standards and Clinical Trial Protocol requirements
  • Encompasses the review of material status, adherence to protocol, clinical design layout, and the assurance that blinding techniques are implemented
  • Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation
  • Ensure timely release of batch for protocol initiation date
  • Release batch within scheduling database
  • Communicates SQDC countermeasures and safety issues to Quality Management
  • Ensures QADC metrics are met or acts to correct

Production Coordinator

Almac Clinical Technologies
11.2016 - 08.2018
  • Met aggressive production and safety goals while minimizing equipment downtime.
  • Inspected, verified and documented quantifiable characteristics of finished goods, comparing against customer specifications and company quality standards to achieve acceptable product.
  • Accurately and timely complete the review/auditing of executed batch records ensuring that quality has been deemed satisfactory throughout manufacturing/assembly/labeling process.
  • Addressed internal supply problems head-on and developed creative solutions to prevent delays and missed targets.

Education

Associate of Arts - Liberal Arts And General Studies

Montgomery County Community College
Blue Bell, PA
05.2016

Skills

  • TrackWise
  • Salesforce
  • MasterControl
  • M-Files
  • CGMP and GDP
  • Correction action planning & Deviations
  • Project Management
  • Change Orders
  • SAP/JDE
  • Project Scheduling
  • Project planning and development

Certification

  • Project Management Training - 2022
  • Six Sigma: Green Belt Training - 2022

Timeline

Project Manager

Catalant
12.2021 - 06.2024

Project Manager

Clinigen
12.2020 - 11.2021

Quality Assurance Documentation Specialist

Clinigen
05.2020 - 12.2020

Quality Assurance

Almac Clinical Technologies
08.2018 - 05.2020

Production Coordinator

Almac Clinical Technologies
11.2016 - 08.2018

Associate of Arts - Liberal Arts And General Studies

Montgomery County Community College

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Kelomi Swint