Summary
Overview
Work History
Education
Skills
Interests
Timeline
Generic

McKinna Macias

San Diego

Summary

Experienced with clinical packaging campaign planning and execution, driving projects from inception to completion within expedited timelines. Utilizes strategic thinking and resource management to streamline processes. Investigated and improved company processes via root cause analysis and CAPAs. Enhance team productivity with a positive and collaborative outlook.

Overview

4
4
years of professional experience

Work History

Associate Project Lead

Catalent Pharma Solutions - Clinical Supply Services
01.2024 - Current
  • Coordinated project timelines and deliverables to ensure seamless clinical trial execution for bottling, labeling, and blistering campaigns
  • Created clinical packaging batch records based on client and cross-functional communication
  • Investigated and executed deviations and change controls via a QMS system and implemented CAPAs to ensure regulatory compliance
  • Procured and created material specifications for packaging components including shippers, inserts, cartons, blister cards, etc.
  • Lead Events committee team and promoted the importance of employee engagement. Organized events like the Spring Extravanganza, Annual Ping Pong Tournament, and BYO Hot Cocoa Day!

Clinical Packaging Engineer Co-Op

Gilead Sciences, Inc.
07.2023 - 12.2023
  • In charge of working with suppliers to ensure the adaption of a redesigned secondary packaging configuration for clinical vial transportation
  • Responsible for performing shipping tests, generating detailed reports on applied stability and clinical protocols, and assessing package effectiveness in terms of security and protection
  • Qualified new blistering equipment in a non-GMP lab, created samples, and performed leak tests on blistering forms

Packaging Intern

Niagara Bottling, LLC
06.2022 - 08.2022
  • Performed a half dozen resin trial tests and ensured resultant bottles remained in-spec to company standards to new resin adoptions
  • Collaborated with cross-functional teams to create an optimized PET/HDPE Trial Datapack to help convey the quality specifications of the resins in comparison to current company bottles
  • Executed section weight and vent testing on the manufacturing floor and produced records based on packaging data

R&D Packaging Intern

Dexcom
06.2021 - 08.2021
  • Analyzed, delivered, and presented new space and cost-efficient palletizations for company products using CAPE software in an expedited timeframe
  • Learned and contributed to the ASTM distribution cycle testing process via performing feasibility analysis
  • Executed product validation procedures, gained experience working with medical device standards like ISO 11607

Education

Bachelor of Science - Industrial Technology And Packaging

California Polytechnic State University, San Luis Obispo
San Luis Obispo, CA
06-2023

Skills

  • Trackwise QMS Certified
  • Project Management
  • Efficient in Microsoft Suite
  • Requirements analysis

Interests

  • Enjoy playing competitive tennis, watercolor painting, and watching cinematic movies in theaters

Timeline

Associate Project Lead

Catalent Pharma Solutions - Clinical Supply Services
01.2024 - Current

Clinical Packaging Engineer Co-Op

Gilead Sciences, Inc.
07.2023 - 12.2023

Packaging Intern

Niagara Bottling, LLC
06.2022 - 08.2022

R&D Packaging Intern

Dexcom
06.2021 - 08.2021

Bachelor of Science - Industrial Technology And Packaging

California Polytechnic State University, San Luis Obispo

Similar Profiles

CREATE PROFILE
McKinna Macias