Quality Assurance Technician 1st Shift

BlueRoot Health
  • Middletown, CT
    1 day ago

    Job Description

    Job Description

    Job Description
    Description:

     

    PURPOSE STATEMENT:  


    The QA Technician performs floor-level quality assurance across manufacturing and packaging. This role executes in-process checks, line clearance and material verification, receiving and storage controls, label review, status labeling, and environmental and hygiene monitoring, and initiates quality records such as nonconformances and deviations. QA Technician responsibilities are shared between the Quality Assurance Team. 


    WHAT YOU’LL DO (MAJOR RESPONSIBILITIES):  

    • Logbook inspections 
    • Preventative maintenance monitoring 
    • Operation and verification of scales and balances (routine accuracy checks) 
    • Hygienic zoning monitoring 
    • Water and air supply testing (potable water, compressed air) 
    • Monitor gowning and hygiene compliance on the floor 
    • Perform in-process weight checks and inspections 
    • Random in-process AQL 
    • Authorizing bottling to continue runs; verify proper materials are used 
    • Raw material weighing & blending / dispensing verification 
    • Equipment cleaning verification and line clearance for each machine 
    • Internal audit assistance 
    • Review and approval of incoming product labels 
    • Receiving and controlled-storage program oversight (conditions, segregation) 
    • Status labeling of materials (quarantine/hold/release/reject tags) 
    • Monitor controlled storage conditions; inventory rotation (FEFO) and expiry (pick lists) 
    • In-process allergen swab testing 
    • Review service-vendor logs 
    • Initiate and document nonconformance reports and deviations 
    • Participate in day-to-day logs and trackers (calibration, PM, EM, complaints, deviations, CAPAs, training) 
    • Personal hygiene, dress code and visitor control / visitor logs 
    • Issuing records to bottling 
    • Inventory adjustments and status changes in NetSuite 
    • Repacking, relabeling, labeling of unlabeled bottle stock; producing unlabeled stock 
    • Carry out additional responsibilities as assigned to support departmental and organizational goals 

    WHAT YOU’LL NEED(KNOWLEDGE/SKILLS/EXPERIENCE): 

    • High school diploma or GED required; associate or bachelor's degree in Biology, Chemistry, Food Science, or a related scientific field preferred.  
    • One (1) or more years of experience in Quality Assurance, Quality Control, or manufacturing within a cGMP-regulated environment (dietary supplements, food, or pharmaceuticals) preferred.  
    • Working knowledge of current Good Manufacturing Practices (cGMP), FDA 21 CFR Part 111, and Good Documentation Practices (GDP).  
    • Strong attention to detail with the ability to perform in-process inspections, line clearance activities, and accurate documentation.  
    • Basic proficiency with Microsoft Office, including Excel; experience with electronic Quality Management Systems (eQMS), NetSuite, or similar ERP/QMS platforms is preferred.  
    • Ability to read, understand, and follow Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and work instructions.  
    • Ability to work in a manufacturing environment and perform routine inspections while standing and walking throughout the production floor. 

    PHYSICAL REQUIREMENTS: 

    • Must be able to lift and/or move up to 50 pounds occasionally, with or without reasonable accommodation.  
    • Frequently stand, walk, bend, stoop, kneel, reach, and climb stairs throughout the workday.  
    • Perform repetitive hand and wrist movements associated with sampling, inspections, documentation, and use of quality equipment.  
    • Work safely around manufacturing equipment and moving mechanical parts.  
    • Visual acuity sufficient to inspect products, labels, packaging components, documentation, and equipment, including close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.  
    • Work in a manufacturing environment with exposure to airborne powders, dust, noise, and common food or botanical allergens.  
    • Wear required personal protective equipment (PPE) and cGMP attire, including non-slip footwear, hair net, beard net (when applicable), face mask, gloves, and any additional PPE required for assigned areas.  
    • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. 
    Requirements:


    Numbers & Facts

    LocationMiddletown, CT

    Skills

    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Check Processingunmatched
    • Chemistryunmatched
    • Cleaning Equipmentunmatched
    • Code of Federal Regulationsunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Depth Perceptionunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • ERP (Enterprise Resource Planning)unmatched
    • Environmental Monitoringunmatched
    • FDA (Food and Drug Administration)unmatched
    • Food Scienceunmatched
    • High School Diplomaunmatched
    • Internal Auditunmatched
    • Lift/Move 50 Poundsunmatched
    • Manufacturingunmatched
    • Manufacturing Equipment Maintenanceunmatched
    • Microsoft Excelunmatched
    • Microsoft Officeunmatched
    • NetSuiteunmatched
    • Physical Demandsunmatched
    • Potable Water Supplyunmatched
    • Preventative Maintenanceunmatched
    • Program Controlunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Sampling Inspectionunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Water Quality Testingunmatched
    • Water Supplyunmatched
    • Zoningunmatched

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