Gabrielle Trauger
Quality Manager at Nordic Cold Chain Solutions- Claim this Profile
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Topline Score
Bio
Credentials
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Certified Quality Process Analyst
ASQ - World HeadquartersFeb, 2017- Nov, 2024 -
Certified Quality Inspector
ASQ - World HeadquartersMar, 2016- Nov, 2024 -
Certified Quality Improvement Associate
ASQ - World HeadquartersDec, 2014- Nov, 2024 -
ASQ Certified Quality Auditor
ASQ - World HeadquartersJan, 2018- Nov, 2024 -
ASQ Certified Supplier Quality Professional
ASQ - World HeadquartersJan, 2018- Nov, 2024
Experience
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Nordic Cold Chain Solutions
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United States
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Packaging and Containers Manufacturing
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1 - 100 Employee
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Quality Manager
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Aug 2021 - Present
-Implements and maintains policies and procedures to ensure adherence to production quality standards.-Monitors and audits processes and products against established standards. -Performs continuous analysis of quality defects and deviations. -Manages quality personnel across six sites. -Coordinates with other departments to ensure continuous improvement within the organization. -Investigates customer complaints and facilitates corrective actions. -Maintain and provide training of the Quality Assurance Program and Manual. -Monitors Supplier's quality monthly and addresses any quality issues.-Leads Customer and Supplier audits. -Creates reports and analyzes data to determine if any changes/improvements are necessary to the quality processes.
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Sharp Services
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Supplier Quality Analyst
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Oct 2018 - Aug 2021
-Develop/maintain Supplier Quality Program-Review/approve Incoming Specifications-Address Deviated Material Reports with Suppliers-Perform ongoing monitoring and management of suppliers-Lead supplier quality audits-monitor calibrations
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Lead Incoming Quality Inspector
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Jun 2015 - Oct 2018
• Reviews all Incoming inspection documentation prior to approval. • Reviews protocols.• Supervises Incoming Quality activities.• Scheduling/assignment of staff to meet inspection requirements.• Completion and documentation of subordinate training on GMPs. • Processes Deviated Material Reports and Events. • Monitors movement of controlled drug.• Initiates CCRs.
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Incoming Quality Inspector
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Jul 2013 - Jun 2015
• Samples and inspects Incoming components and bulk.• Initiates Deviated Material Reports and Events.• Pulls samples requested by internal and external customers. • Uses Global Vision, LVS, Calipers, Keyence, micrometers.
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Fres-co System USA, Inc.
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United States
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Packaging and Containers Manufacturing
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100 - 200 Employee
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Quality Assurance Technician
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Nov 2009 - Oct 2012
• Performs Process Monitoring Inspections to verify compliance to product and process control plans • Assists in timely completion of monthly GMP inspections • Participates in internal audits of quality processes • Manages corrective action database for audits • Tags & dispositions all hold material in accordance with MRB directives • Audits and improves plant sanitation program• Assists the preparation for 3rd party and customer audits • Participates in root cause analysis of problems that relate to quality system deficiencies • Supports document control program
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Education
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Montgomery County Community College
Associate's degree, Business Administration and Management, General