Danchelle Hedgepeth
Spring Hope,USA
Summary
Professional with extensive experience at Pfizer, specializing in regulatory compliance and production operations. Demonstrated expertise in data management, ensuring strict adherence to cGMP standards. Recognized for leadership and collaboration in high-pressure environments, consistently maintaining data integrity and confidentiality. Strong work ethic and adaptability, with proven ability to master new skills quickly and work effectively independently.
Overview
22
22
years of professional experience
Work History
Defect Lab Analyst 1
Pfizer
Rocky Mount, NC
01.2021 - Current
- ALCOA trained
- Equipment serialization
- Print Coordinator (PDocs) Official Print
- Data interpretation and documentation
- Formulate Solution (MS&T Room) for Priority Kits
- Maintain laboratory compliance
- Collaborating with Engineering Project kits
- Sample and Preparation and analysis
- Operate several analytical instruments
- Locate and manual hand wash vials, stoppers, syringes, and ampoules
- Ensure units are essentially free of particulate and integrity/workmanship defect prior to kit creation
- Operate Autoclave, Ampoule sealer, Torch, Hand torch and Hot plate methods
- Organize and complete Batch Records
- Cleaning and Sampling Collection using the MODA system
- Pharma Media Field Run
- Quality and Compliance (Monthly Audit)
Production Operator
Pfizer
Rocky Mount, NC
04.2004 - 01.2021
- Serve as a line coordinator and machine operator
- Planned and laid out work to meet production and schedule requirements.
- Coordinate daily activities on the production line
- Manage changeovers and batch start-ups
- Collaborate with quality, engineering, and laboratory operations as needed
- Ensure accurate and timely documentation in Batch Production Record
- Conduct activities in a safe and GMP manner
- Trained to work in aseptic/classified areas
- Ensure compliance with appropriate SOP's and cGMP's
- Address and resolve issues during critical processes
- Inspect rooms and equipment for cleanliness
- Perform in-process checks of products and components
- Collect samples at required time points per standard operating procedure and ANSI standard (American National Standard's Institute)
- Inspect final product for measurements and defects
- Helped achieve company goals by supporting production workers.
- Reviewed operations and conferred with technical or administrative staff to resolve production and processing problems.
- Visual Inspection (Dabrico certified)
Regulatory Compliance
Pfizer
Rocky Mount, NC
10.2019 - 01.2020
- Review SOPs, policies, and procedures for regulatory alignment
- Ensure that company activities, products and communications comply with global and local regulatory requirements and ethical standards
- CAPA management
- Change control processes
- Regulatory inspection support (FDA)
- Organize and file important information
- Ensure data integrity and confidentiality
- Collaborate and meet expectations for the company's goal
- Deviations and non-conformance handling
Education
Associate of Applied Science - Electronic Medical Records
Miller Motte College Online
Wilmington, North Carolina02.2018
Skills
- Adaptability to new techniques
- Training and development
- Operations leadership
- Time management
- Data entry
- Computer proficiency
- Precision and attention to detail
- Record filing
- CMS-1500 billing system (basic)
- Emergency procedures and standards
- Scheduling and workflow coordination
- HIPAA compliance and confidentiality
- Medical law and ethics
- Medical terminology
Timeline
Defect Lab Analyst 1
Pfizer
01.2021 - Current
Regulatory Compliance
Pfizer
10.2019 - 01.2020
Production Operator
Pfizer
04.2004 - 01.2021
Associate of Applied Science - Electronic Medical Records
Miller Motte College Online