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Quality Assurance Associate

Company: System One
Location: Durham
Posted on: January 12, 2021

Job Description:

Title: Quality Assurance AssociateLocation: Durham, NCDuration: Direct HireSchedule: Full Time M-F, flexible to work longer hours to meet production needs and overtime is requiredTarget Start Date: ASAPResponsibilities: * Perform all required testing & sampling for Manufacturing and Packaging batches. * Perform incoming inspections and outgoing inspections of finished product batches. * Perform verifications using special instruments (Caliper, Balance, etc.) to assign final Approval to Labeling, Packaging and Raw Materials.* Perform all required testing & sampling of batches in progress and products to be packaged.* Perform line clearances of the manufacturing/ packaging areas and equipment* Verify and confirm issuances and reconciliation of product and components.* Performing Cleaning Verification/Validation Swabbing of Equipment* Verify that temperature/humidity, D.I. Water and Magnehelics are all in range/good working condition* Participate in Stability/Validation product Sampling* Review and Approve Preventive Maintenance or Work Orders; (if necessary)* Capture critical information for Customer Complaint/Deviation investigations/CAPA/Change Controls (when necessary) * Handle various requests from departments for developmental or investigative reasons* Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves* Data Entry of Finished Product Information into the APR (Annual Product Review) system* Complete all applicable training forms in a timely manner and forward to document control for archival* Preparation and issuance of the BMR, BPR, validation protocol, validation report, SOP's* Collection and inventorying of Retain and/ or Stability Samples* Review of equipment, machine, area qualifications * Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)* Replace Temperature/Humidity Charts weekly* Maintaining QA supply inventory* Perform other duties as assigned* 50% Testing and Sampling for Manufacturing and Packaging Batches* 25% Perform incoming inspections and outgoing inspections of finished product batches* 25% Perform verifications using special instrumentsRequirements: * ***BIGGEST REQUIREMENTS IS IN-PROCESS QA EXPERIENCE (on the floor) and BATCH RECORDS**** Experienced in proper documentation and correction practices* Must be a Team player able to effectively communicate with QA Supervisor, QA, Quality Control, Production, and Supply Chain to meet finished product release goals* Be able to work long hours to support production requirements* Be available for overtime, including weekends, as needed for production support * Possess the ability to analyze information and make consistently good decisionsJoule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Durham , Quality Assurance Associate, Other , Durham, North Carolina

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