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Guerbet · 1 day ago

Distribution Center Quality Technician

Cincinnati metropolitan area, OH

Full-time

Onsite

Entry Level

2+ years exp

Guerbet is seeking a Distribution Center Quality Technician responsible for inspecting and auditing documentation and processes related to medical device shipments. The role involves ensuring compliance with quality standards, supporting audits, and maintaining an efficient work environment within the Distribution Center.

Health CareMedicalPharmaceutical

Hiring Manager

Kris Adams

Responsibilities

Serve as the Primary Quality Auditor for Domestic and International Outbound Shipments to ensure compliance with local procedures and product requirements

Serve as the Lead Auditor to ensure all special instructions are adhered to for Export Shipments for the Distribution Center’s varying customers

Serve as the primary contact for creating and sending requested Quality Documents on behalf of the Distribution Center

Recommend and implement controls to ensure that quality standards are met

Support the development and launch of standard operating procedures for the Distribution Center

Support 3rd-party, regulatory and customer audits of the QMS, as well as requests for records

Serve as lead investigator for all Quality Complaints or Nonconformances directed to the Cincinnati Distribution Center including tracking, reporting, and investigating quality errors by the DC Team

Perform root cause analysis to determine underlying problems. Implement corrective and preventive actions to prevent recurrence of issues

Work closely with Operations Engineering, Quality, Purchasing, Planning, and Production to achieve business objectives

Actively help to maintain an efficient work environment by ensuring 6S Standards are met, driving quality and organization of the Distribution Center

Perform duties as a back-up Quality Technician for operations when necessary

Support the Quality efforts of the Distribution Center Team and the Site Quality Department

Provide quality updates to the Distribution Center Team at the daily tier meetings, including the Distribution Quality KPIs

Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately

Responsible for ensuring DC compliance with GxPs and other regulatory requirements

Responsible for participation in all Safety aspects of the plant

Responsible for demonstrating initiative, self-direction, and ability to make decisions

Requires a solid understanding of Good Documentation Practices (GDP) aligned with ALCOA+ principles, as well as the ability to effectively apply associated methods and tools in daily operations

Must understand and adhere to standard operating procedures (SOP’s) in a pharmaceutical manufacturing environment and be able to apply Good Manufacturing Practices

Understand and follow Good Manufacturing Practices (GMP)

Requires successful completion of assigned training

Perform other duties, special assignments and projects as directed by Quality or Distribution Center management

Follow First-In First-Out “FIFO” practices

Qualification

Quality AuditingManufacturing PracticesDocumentation PracticesRoot Cause AnalysisMicrosoft OfficeQuality ComplianceAnalytical SkillsProblem-Solving SkillsCommunication SkillsInterpersonal Skills

Required

Minimum Associate's degree required

Two years of applicable work experience, or the equivalent combination of education, training and experience required

Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio)

Requires a solid understanding of Good Documentation Practices (GDP) aligned with ALCOA+ principles, as well as the ability to effectively apply associated methods and tools in daily operations

Must understand and adhere to standard operating procedures (SOP's) in a pharmaceutical manufacturing environment and be able to apply Good Manufacturing Practices

Understand and follow Good Manufacturing Practices (GMP)

Requires successful completion of assigned training

Ability to read, interpret, understand, and apply written instructions

Ability to receive and follow verbal directions

Ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations

Requires extreme attention to detail

Strong communication and interpersonal skills, with the ability to interact professionally at all levels

Strong analytical, problem-solving, and decision-making skills

Ability to lift to 35 lbs. without assistance

Ability to operate manual and/or electric pallet jacks

Requires sitting for roughly 2-6 hours per day with breaks

Requires keyboard use for roughly 5-6 hours per day with breaks