Assembly Technician Team Lead

Celeste Gammel

Assembly Technician

Parker, Colorado

Summary

● 10 plus years of experience in the manufacturing industry working as a Team Lead

● Ability to direct, manage and train individuals to success

● Dynamic and motivated professional with a proven record of building relationships, managing day-to-day priorities from concept to completion.

● Consistently demonstrate exceptional communication skills, the ability to make critical decisions during challenges

● Adaptable and transformational leader with an ability to work independently, continuously developing opportunities that further establish organizational goals

● Skilled, organized and dedicated with a very strong work ethic and positive attitude Education

Northeastern University

Sterling, CO

1999-2000

● Degree Program: Bachelors of Science in Engineering

● NCAA Early Recruit College Basketball Athlete

● Accepted Full-Ride Scholarship for Basketball

Hinkley High School

Aurora, CO

1995-1999

● Graduated - High School Diploma

● Varsity All Star Athlete

Basketball, Tennis, Soccer, Softball

Certifications

● Certified UltraSonic Cleaning

● Certified Trainer - Final Inspection, Bagging, Blast and UltraSonic Cleaning

● Certified Bagger in Packing Quality and Standards

● Certified ISO Final Inspection Training and Quality Inspector

● ISO8, ISO7, and ISO5 Cleanroom certified

● Perform appropriate aseptic gowning

● Certified GDP inspector

● Certified Filling operator

Professional Experience

Mikron

Englewood, CO

2022-2024

Assembly Technician

● Certified in ISO7 gowning

● Complete batch record by verifying that all sections pertinent to the manufacturing process are accurate and complete

● Perform duties per standard operating procedures for the preparation of product manufacturing areas and equipment to include; cleaning, labeling, staging, and equipment calibrations.

● Complete batch record by verifying that all sections pertinent to the manufacturing process are accurate and complete

● Follow SOPs, product batch record instructions, and corresponding quality documentation in detail.

● Knowledge of ISO/FDA/GMP procedures

● Help produce new policy and protocols for the clean room

● Organizing training and educational manuals for the production team

● Assemble mechanical components, test and document all top level product

● Ensure all products are built and tested according to the documented procedures, and all forms are completed correctly.

● Maintain the cleanroom and all associated equipment. Including scheduling daily room maintenance for bioburden testing and air quality testing.

● Provide support and feedback to quality and manufacturing engineering VPI Compounding

Englewood, CO

2021-2022

Pharmaceutical Manufacturing Tech

● Certified in ISO8-ISO5 gowning

● Complete batch record by verifying that all sections pertinent to the manufacturing process are accurate and complete

● Utilizing and handling appropriate supplies and raw materials for proper aseptic manufacturing

● Drug substance manufacturing, parenteral filling, use of isolator equipment, manual and automatic inspection, labeling, packaging, component receipt and verification, and scheduled area sanitization.

● Perform appropriate aseptic gowning.

● Certified filling operator with vials, syringes, dropper bottles *********@*****.***

Leiters

Englewood, CO

2019 - 2021

Pharmaceutical Manufacturing Tech

● Certified filling operator with vials, syringes, dropper bottles, and On Q pumps

● Multiple Machine setup.

● Vial extractoring machine.

● Experience in an FDA-regulated environment.

● Track and report all activities related to raw material/component procurement equipment readiness, analytical process transfer, manufacturing document creation.

● Strong process improvement methodology, working with batch fine/speciality chemicals GMP guidelines.

● Certified in ISO8-ISO5 gowning

● Well versed in EHS regulatory compliance relating to pharmaceutical production including OSHA, cGMPs and PMS requirements.

● Formulating various pharmaceutical medications for a variety of providers and hospitals.

● Provides drug product manufacturing process knowledge for formulation and production

● Strong project management, interpersonal, cross- cultural, communication, negotiation and problem solving skills required.

● Complete batch record by verifying that all sections pertinent to the manufacturing process are accurate and complete.

● Perform duties per standard operating procedures for the preparation of the drug product manufacturing areas and equipment to include; cleaning, labeling, staging, and equipment calibrations.

● Bulk drug substance manufacturing, parenteral filling, use of isolator equipment, manual and automatic inspection, labeling, packaging, component receipt and verification, and scheduled area sanitization.

● Follow SOPs, product batch record instructions, and corresponding quality documentation in detail.

● Utilizing and handling appropriate supplies and raw materials for proper aseptic manufacturing.

● Perform appropriate aseptic gowning.

Quantum Clean Technologies

Phoenix, Arizona

2013-2019

Cleanroom Manufacturing Technician IIII, Team Lead

● Support and participate in efforts to drive continuous improvement and work towards achieving department goals within the cleanroom.

● Providing training and leadership to all team members.

● Participate in self-directed team activities, adhering to all company and department work and safety rules

*********@*****.***

● 6 S auditor - visual inspection of all areas in the building, to ensure safety policies and procedures are being followed.

● Performing other duties as assigned by Supervisor and Site Manager

● Final Inspection and Bagging

● Expert in Final Inspection Quality Manual, Quality Management Systems, Quality Management Policies, Quality Goals and applicable laws and regulations as they apply within Quantum Clean.

Intel

Chandler, Arizona

2012-2013

Cleanroom Manufacturing Technician, Team Lead

● Operator of auto bagger

● Certified Technician working in the Wafer Fab

● Advanced knowledgeable on Intel’s Auto Bagging policies and procedures

● Certified auto bagger and manual bagger

● Knowledge of ISO/FDA/GMP procedures

● Managing and training large team of 12 technicians

● Completed all planned Quality and Compliance training within the defined deadlines. Comcast Cable

Denver, Colorado

2009-2010

Collections Agent

Inbound and outbound collection agent

● Awarded “Gold” for 3 months ($140,000.00 - $130,000.00)

● Awarded “Silver” for consecutive months

● Team Oriented, provided consistent support and excellent customer service. Linebarger Goggen Blair & Sampson, LLP

Denver, Colorado

2008-2009

Collections Agent

● Responsible for reaching monthly goals set by the company

● Exceeded all expectations and achieved monthly revenues of $50,000

● Commissioned Monthly

● Inbound and outbound agent

*********@*****.***

St. Jude Medical Hospital

Scottsdale, Arizona

2007-2008

Inspection Specialist

● Operator of auto bagger

● Team Leader for product inspection

● Responsible for quality control-final inspection of product

● Cleanroom Certified

● Expert on used of high power microscope, used in day-to-day routine Capacity Builders, LLC

Centennial, Colorado

2005-2007

Staffing Specialist

● Recruit, interview and process potential employees for nationwide projects

● Complete background checks and maintain employee timesheets

● Generate, build and maintain professional customer relationships

● Placement of nationwide ads online and in print

● Document and process lien information for accounts receivables Medtronic

Tempe, Arizona

2004-2005

Production Specialist, Team Lead

● Recruit, interview and process potential employees for nationwide projects

● Medical Processing and assembling of Pacemakers under a microscope

● Feed-Through Operator

● Grit blast operator

● Team Leader in Production Division

*********@*****.***

America West

Phoenix, Arizona

2004-2005

Ramp Agent

● Ramp service agent

● Marshal aircrafts, loading/unloading, baggage, servicing the aircraft, assisting with pushback and towing, deicing and other duties as assigned.

● Airport Ramp Certified in Ground Operations, Quality, audits and operation *********@*****.***

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