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Kutol Products Company, Inc. · 3 months ago

Quality Assurance Technician-Label Control 3rd Shift

Sharonville, Ohio, United States

Full-time

Onsite

New Grad, Entry Level

$21/hr - $22/hr

Kutol Products Company is a thriving hand soap and hand sanitizer manufacturer operating out of their Silver LEED Certified facility in Sharonville, Ohio. They are currently seeking a Quality Assurance Technician/Label Control Technician to oversee the label area and perform various QA functions to ensure compliance with government regulations and customer requirements.

Clean EnergyFacilities Support ServicesManufacturing

Responsibilities

Perform visual and dimensional inspection of incoming labels using measuring instruments, specifications and drawings and determine compliance/release or rejection

Provide oversight of the controlled label area by performing receipt, approval, issuance audits, count verifications, inventory and reconciliation of labels

Perform daily inspections of the Manufacturing areas and balance/scale checks. Work with Manufacturing Management/Supervision to ensure quality issues are addressed

Review manufacturing records for disposition. Disposition Finished Product in SAP (i.e. Release, Reject, Quarantine)

Review Work in Process, Reprocess and Rework requests for additional requirements and provide Quality approval to proceed

Review and Issue packaging instructions/specifications, formulas, Certificates of Analysis (CoA), Certificates of Manufacture (CoM) and CoA/CoM templates

Assist in writing/revision of Standard Operating Procedures (SOP’s). Issue SOPs for approval, distribute and keep SOP manuals up to date with current revisions

Maintain Master Manufacturing Records in accordance with regulatory requirements

Conduct quality investigations as directed and prepare findings

Provide support to internal and external customers

Support education of others in current Good Manufacturing Practices, applicable regulations, and company Continuous Improvement initiatives

Compile all required reports and documents on the performance of the above duties

Serve as back-up to QA Incoming Inspection when needed

Perform or assist with Internal Audits in compliance with cGMP regulations

Other projects or duties as assigned

Qualification

CGMP complianceQuality inspectionsSAPStandard Operating ProceduresCertificates of AnalysisAttention to detailTeam collaborationProblem-solving

Required

Oversight of the label area, including receipt, approval, issuance, counts, accountability and inventory

Perform QA functions to include daily manufacturing cGMP inspection and balance/scale checks

Product disposition

Preparation of CoA/CoM

Preparation, revision and issuance of standard operating procedures

Preparation, revision and issuance of packaging instructions/specifications

Provide support to internal and external customers in compliance with government regulations and customer requirements

Provide support during customer and regulatory audits

Perform visual and dimensional inspection of incoming labels using measuring instruments, specifications and drawings and determine compliance/release or rejection

Provide oversight of the controlled label area by performing receipt, approval, issuance audits, count verifications, inventory and reconciliation of labels

Perform daily inspections of the Manufacturing areas and balance/scale checks

Work with Manufacturing Management/Supervision to ensure quality issues are addressed

Review manufacturing records for disposition

Disposition Finished Product in SAP (i.e. Release, Reject, Quarantine)