Summary
Overview
Work History
Education
Skills
Timeline
Generic

Colleenena Jennings

Durham,NC

Summary

Currently employed as an Operations technician within the pharmaceutical manufacturing industry. Seeking new opportunities and experiences. Knowing how to properly follow SOP and execute batch records. Trained in PASX and SAP and Delta V.

Overview

2
2
years of professional experience

Work History

Associate Technition

Novo Nordisk
Durham , NC
09.2022 - Current
  • Accurate in executing batch production processes, ensuring precision, adherence to protocols, and seamless product development
  • Compliant and understanding of FDA guidelines and regulations
  • Efficient in Quality control and Assurance
  • Strong understanding of GDP requirements
  • Demonstrated expertise in formulating oral pharmaceutical products, overseeing the production of tablets, capsules, and liquid formulations.
  • Maintained high-quality standards for oral finished products through meticulous quality control checks and compliance with regulatory requirements.
  • Conducted analytical testing to verify product potency, purity, and stability, contributing to the overall quality assurance process.
  • Proficiently operated and maintained specialized equipment essential for oral finished product manufacturing.
  • Ensured accuracy in documentation of manufacturing processes, maintaining detailed batch records and production reports.
  • Adhered to GMP to meet industry regulations and uphold product quality standards.
  • Maintained a sterile and controlled manufacturing environment by strictly following cleanroom protocols and practices.
  • Successfully identified and resolved challenges during the manufacturing process, contributing to the overall efficiency and quality improvement.
  • Implemented initiatives to enhance operational efficiency, reduce waste, and elevate the overall quality of OFP manufacturing.
  • Conducted root cause analyses for deviations or discrepancies in the manufacturing process, implementing corrective and preventive actions.
  • Experience in new facility and project start-up

Associate Technician I

merck
Durham, NC
10.2021 - 09.2022
  • Properly follows SOP
  • Maintain inventory by performing cycle counts in sterile supply area
  • Trained in PASX, SAP, Delta V
  • Execute batch records
  • Trained in equipment: 200 and 2000L SUMs, WM pumps, Toledo pH/ conductivity meter, bench top/ floor scales, Terumo and Sartorious tube welders, stir bases and fume hoods.
  • Conduct/participated in AP1, Buffer, Acetone formulations.
  • Attend daily tiers and touchpoints.
  • Handle/discard waste produced from formulations.
  • Understands how to properly discard of hazard chemicals.
  • Maintain a clean and orderly work environment.
  • Understands how to properly store completed samples into freezer units.
  • Efficient at meeting CGMP requirements.
  • Understands importance of maintaining current training.
  • Strong understanding of aseptic environments.
  • Strong understanding on how to formulate and produce cell growth and development.
  • Strictly followed cleanroom protocols to maintain a sterile environment, preventing contamination.
  • Proficient in proper gowning and hygiene procedures and the use of PPE to minimize the risk of introducing contaminants into the aseptic environment.
  • Executed sterilization processes for equipment and materials, ensuring that all components entering the aseptic environment were free from viable microorganisms.
  • Conducted routine environmental monitoring, including air and surface sampling, to assess and maintain the cleanliness and sterility.
  • Operated isolators and laminar flow hoods proficiently.
  • Experience in new facility and project start-up

Education

Associate of Science - Biology

Durham Technical Community College
Durham, NC
12-2024

High school diploma -

Northern Vance High School
Henderson, NC
06-2016

Skills

  • CGMP Mindset
  • Strong understanding of GDP
  • Aseptic behavior
  • Uphold data integrity
  • Completed train the trainer program
  • Greater than 95% in MyLearning
  • Maintaining cleanliness on production floor
  • Quality doc/veeva vault
  • Warehouse and logistics
  • Able to enter safety incidents into Enablon
  • Strong understanding of PasX and SAP

Timeline

Associate Technition

Novo Nordisk
09.2022 - Current

Associate Technician I

merck
10.2021 - 09.2022

Associate of Science - Biology

Durham Technical Community College

High school diploma -

Northern Vance High School

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Colleenena Jennings