Position Details

Type Not Specified

Experience entry

Exp. Years 0-2 years (preferred)

Education High School Diploma or equivalent

Category Healthcare & Medical

About this role

Quality Assurance Coordinator - Data Reviewer supports administration and document control of the laboratory Quality Assurance system. The role maintains SOPs and forms, manages records/data control processes, and helps track Change Control Requests and customer method documentation.

Key Responsibilities

Assist in administration and document control of the Quality Assurance system
Maintain SOPs and forms and manage SOP routing, indexing, publishing, and archiving
Manage records/data management systems for records control requirements
Manage Form/Worksheet Control System (numbers, revision codes, filing) and track Change Control Requests
Support customer methods and protocols/reports including Method Transfer, Method Validation, and Stability

Technical Overview

This is a documentation-heavy Quality Assurance support role focused on maintaining SOP and form control systems, records/data management for quality assurance compliance, and change control request tracking. It also supports customer method workflows including Method Transfer, Method Validation, and Stability documentation.

Ideal Candidate

The ideal candidate is an entry-level Quality Assurance Coordinator with strong attention to detail and intermediate computer skills. They can support document control and Quality Assurance system administration, maintain SOP and form control, and track Change Control Requests while supporting customer methods including Method Transfer, Method Validation, and Stability.

Must-Have Skills

High School diploma or equivalentProficient English language skillsBasic mathematical skillsIntermediate reasoning skills/abilitiesIntermediate computer skillsStrong attention to detailAbility to manage and coordinate multiple projects in a fast-pacedhighly professional environment.document controladministration of the Quality Assurance systemadheres to internal standardspoliciesand procedures

Nice-to-Have Skills

0-2 years of job related experience

Required Skills

document controlQuality Assurance system administrationSOPsforms maintenancerecords/data management systemrecords control requirementsForm/Worksheet Control SystemChange Control RequestsMethod TransferMethod ValidationStability

Hard Skills

document controlQuality Assurance system administrationEHS site maintenanceNorth American Operations Procedures (processes SOPsroutes SOPs for routine reviewmaintains a current index for each section of the Manualassigns numbers to new SOPspublishes and approves SOPs into the appropriate department foldersroutes SOPs to other sitesand archives SOPs)SOPs and forms maintenancerecords/data management systemrecords control requirementsrecords controlquality assurance information conversionssystems automationForm/Worksheet Control SystemChange Control Requests trackingcustomer methodsMethod TransferMethod ValidationStabilityadministrative matters customer questions

Soft Skills

efficient customer servicecultivates trust and reliabilityattention to detailability to manage and coordinate multiple projects in a fast-pacedhighly professional environmentproblem-solvingintermediate reasoning skills/abilitiescommunication

Industry & Role

Industry Manufacturing

Job Function Maintain QA documentation, records control, and change control administration for laboratory compliance.

Role Subtype QA Lead

Keywords for Your Resume

Quality Assurance Coordinator - Data ReviewerQuality Assurance Coordinatordocument controlQuality Assurance systemEHSEnvironmentHealthand Safety (EHS)SOPsStandard Operating Procedures (SOP)Manualrecords/data management systemrecords controlForm/Worksheet Control SystemChange Control Requestscustomer inquiriesMethod TransferMethod ValidationStabilityadministrative mattersattention to detailEnglish language skillsintermediate computer skillsmultiple projectsfast-paced

Deal Breakers

High School diploma or equivalent (Required), Proficient English language skills (Required), Strong attention to detail (Required), Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment (Required)

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