Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Carmen Darwin

North Augusta,SC

Summary

To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Process Operator

Kimberly Clark
10.2022 - Current
  • Reported to shift supervisor on production status, problems and deviations.
  • Maintained compliance with health, safety, and environment practices.
  • Isolated and prepared equipment for corrective and scheduled maintenance procedures.
  • Observed all safety rules and regulations and encouraged others to do same, effectively reducing work-related injuries.
  • Efficiently operated all equipment and machinery according to manufacturer instructions.
  • Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
  • Inspected finished products for quality and adherence to customer specifications.
  • Investigated processing errors and malfunctions, resolving issues with minor machine repairs.
  • Performed general equipment maintenance and repair to minimize downtime.
  • Maintained organized work area by cleaning and removing hazards.
  • Organized and prepared workstations and materials needed for operations to maximize productivity.
  • Adjusted machines to increase productivity for runs.
  • Assembled products according to changing daily work orders and specific customer needs.
  • Inspected products and machines to maintain quality and efficiency.

Quality Technician

Generac Power Systems
11.2021 - 01.2023
  • Initiated quality PQI, PQH and daily summaries of quality audits performed
  • Audited processes and materials being used during production and proper tool usage to achieve correct end results
  • Performed weekly torque check on production tools
  • Train operators on procedures and trained new quality technicians
  • Reported to Quality supervisor all defects,
  • Use electronic batch in ETQ to log floor production audits,
  • 3 continuous improvement projects for AM and process improvement
  • Created official quality documents to be used throughout the site
  • Use of power point, excel and word as well as creating graphs to track daily progress and defects also
  • Worked with change management documents and BOMs

Melt Extrusion Operator

Zeus
06.2021 - 08.2021
  • Melt extrusion heat shrink operator
  • Worked with vinyl extrusion machinery making tubing for medical grade catheters and wire wraps.
  • Performed work according to BOMs specifications and blueprints.
  • Used several measuring devices such as micrometers, calipers, pin gauges
  • Inspected parts for defects and quality
  • Packaged finished product
  • Maintained compliance with health, safety, and environment practices.
  • Isolated and prepared equipment for corrective and scheduled maintenance procedures.
  • Observed all safety rules and regulations and encouraged others to do same, effectively reducing work-related injuries.
  • Efficiently operated all equipment and machinery according to manufacturer instructions.
  • Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
  • United way member in Aiken County, SC

Sr Fermentation/ Down Stream Technician

Manus Bio
08.2019 - 06.2021
  • August
  • Start Year 2019
  • End Month June
  • End Year 2021
  • Pilot plant fermentation operator for a bio fuels start up operation, lab Technician and Down Stream Technician
  • Performed weekly swab testing in production areas and QC testing methods for density, content, gram staining, HPLC and
  • Created official documents for the Department such as SOPs and Job Aids
  • Issued work permits for contractors and Manus personnel for all levels of permitted work
  • Performed monthly swab samples for Down Stream Department and created documentation to submit samples and track what samples need to be taken and when
  • Created job improvement boards to track standard work and and process defects and improvements, ordered supplies and parts for the down stream department
  • Created inventory spreadsheets to track available materials both in process and raw materials
  • Created work flow boards to standardize processes and report defects and adjustments to process for the Down Stream Process
  • Confined Space qualified
  • Ran various types of process equipment such as filtration equipment (bag filters), separation equipment (filter Press) and evaporation equipment.
  • Made fermentation batches according to recipes.
  • Tested batches in lab for variables
  • Monitored 24 hr batch by way of Aspen tracking system and Delta V
  • Ordered raw materials for department and created Lean Manufacturing standards for Department
  • Monitored Utilities during batch creation
  • Stream processing area. ISO9 Cleaning for the GMP cleaning of process areas daily and at end of runs which included CIP, COP and SIP and tracking systems for these processes.
  • Set up Equipment for process and CIP using a manual jumper system of liquid transfer
  • Maintained compliance with health, safety, and environment practices.
  • Isolated and prepared equipment for corrective and scheduled maintenance procedures.
  • Observed all safety rules and regulations and encouraged others to do same, effectively reducing work-related injuries.
  • Efficiently operated all equipment and machinery according to manufacturer instructions.
  • Used problem-solving and issue-resolution skills to promptly and successfully address production problems.


Fractionation Lead

Takeda Pharmaceuticals
05.2016 - 08.2019
  • Sr Pharmaceutical manufacturing technician and lead ISO 8 and 9.
  • Team lead over Zone 1 including 15 members of the team
  • Worked closely with Supervisor and managers as a liaison during production
  • Supervised standard work, audited daily processes for safety and quality issue, initiate continuous improvement, performed daily production meetings
  • cGMP compliance
  • Routine maintenance, initiated maintenance work orders
  • Delta V tracking system
  • Trouble shooting process down time, and
  • Track planning and schedule adherence during Production and report gaps and downtime
  • Involved with Start up activities, worked closely with Engineers and Quality on equipment validations, process validations and improvements
  • Created standard work procedures documents, SOP's Job aids, and training new employees
  • Created work flow boards to standardize processes and report defects and adjustments to process for the Buffer area during start up and during validations
  • ISO8 Clean lead for the GMP cleaning of process areas daily and at end of runs which included CIP, COP and SIP and tracking systems for these processes.
  • A member of the Women in Manufacturing group on site.
  • Processing technician in the Precipitation area
  • Created and submitted a Kaizen for an improvement for Buffer and Precipitation jumper identification, Created a power point training.
  • Performed redlining SOP's for yearly audits and updated information for follow up
  • Electronic Batch operation
  • Batch lab sampling for viscosity, microbial, conductivity and pH as well as sampling of clean equipment after CIP.
  • Set up Equipment for CIP using a manual jumper system for liquid transfer
  • Maintained compliance with health, safety, and environment practices.
  • Isolated and prepared equipment for corrective and scheduled maintenance procedures.
  • Observed all safety rules and regulations and encouraged others to do same, effectively reducing work-related injuries.
  • Efficiently operated all equipment and machinery according to manufacturer instructions.
  • Used problem-solving and issue-resolution skills to promptly and successfully address production problems.

Manufacturing Technician

GSK
09.2014 - 05.2016
  • Pharmaceutical Manufacturing technician
  • Manufacturing technician in Nico and ISO 9
  • Clean room manufacturing.
  • GMP cleaning of process areas daily and at end of runs which included CIP, COP and SIP and tracking systems for these processes.
  • Tested selected products at specified stages in production process for performance characteristics or adherence to specifications.
  • Maintained compliance with health, safety, and environment practices.
  • Isolated and prepared equipment for corrective and scheduled maintenance procedures.
  • Observed all safety rules and regulations and encouraged others to do same, effectively reducing work-related injuries.
  • Efficiently operated all equipment and machinery according to manufacturer instructions.
  • Used problem-solving and issue-resolution skills to promptly and successfully address production problems.
  • Performed line clearance inspections at end of runs,
  • Operated a Turret press and trouble shooting of process issues.
  • Assisted with production in packaging department .
  • Product lab sampling before . during and after run, calibration of equipment and scales before use.
  • Documentation redlining yearly SOP updates
  • Trained coworkers on proper set up for yearly performance plans

Education

No Degree - Business Management

Aiken Technical College
Aiken, SC
06.2025

No Degree - Manufacturing Principles

Rhodes State College
Lima, OH
06.2012

Associate of Arts - Marketing

Chippewa Valley Technical College
Eau Claire, WI
12.1988

Skills

  • Certification ISO 13485 Internal Auditor - QA
  • Biofuels Biotechnology
  • Manufacturing Bloodborne Pathogens
  • Chemical Process Development
  • Confined Spaces
  • Continual Improvement Process
  • Continuous Manufacturing Systems
  • Datasheets Drug Product Manufacturing
  • Emergency Response Training
  • Emergency Spill Response
  • Employee Management
  • Fall Arrest Harnesses Fall Protection Training
  • Fermentation
  • Fire Safety
  • Fractionation Hazard Communications (HazCom)
  • Hazard Controls
  • Industrial Manufacturing Processes
  • Lockout Tagout
  • Manufacturing Process Validation
  • Manufacturing Systems
  • Mechanical Aptitude
  • Mechanical assembly
  • Mechanical skills Mechanical Tool usage
  • Microorganisms
  • Packaging machinery
  • Passenger Transportation
  • Pathogens
  • People Management
  • Personal Protective Equipment (PPE)
  • Pharmaceutical Manufacturing
  • Quality Assurance
  • Quality Auditor
  • Quality Control
  • SAP
  • Supply chain/transportation
  • Safety Training
  • Ergonomics Training
  • Torque
  • Warehouse & Logistics
  • Warehouse Equipment
  • Warehouse LMS knowledge
  • Workplace Management
  • Class B CDL
  • Autonomous Maintenance (AM) continuous improvement Trainer
  • 6S
  • Microsoft systems
  • Fork truck
  • Preventative Maintenance (PM)
  • Train the Trainer
  • Validations (IQ, OQ, PQI, SQI, CQV, QIE, PQH)

Certification

ISO 13485 Internal Auditor - QAI Country United States of America Certification Number Issued Date 12/17/2020

Timeline

Process Operator

Kimberly Clark
10.2022 - Current

Quality Technician

Generac Power Systems
11.2021 - 01.2023

Melt Extrusion Operator

Zeus
06.2021 - 08.2021

Sr Fermentation/ Down Stream Technician

Manus Bio
08.2019 - 06.2021

Fractionation Lead

Takeda Pharmaceuticals
05.2016 - 08.2019

Manufacturing Technician

GSK
09.2014 - 05.2016

No Degree - Business Management

Aiken Technical College

No Degree - Manufacturing Principles

Rhodes State College

Associate of Arts - Marketing

Chippewa Valley Technical College

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Carmen Darwin