Quality Assurance Technician-Label Control 3rd Shift

Kutol Products Company • Sharonville, OH

112d • $21

About The Position

Allow me to introduce you to Kutol Products Company, we are a thriving hand soap and hand sanitizer manufacturer operating out of our Silver LEED Certified facility in Sharonville, Ohio. We process and package both cosmetic and drug formulas that work with our proprietary dispensing systems across the country and beyond. We are currently seeking a Quality Assurance Technician/Label Control Technician to join us in our purpose of providing 'Clean Hands for a Healthy World.' At Kutol our QA Technicians/Label Control Technician Provide 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 and provide support to internal and external customers in compliance with government regulations and customer requirements. Provide support during customer and regulatory audits. Provide support to the Incoming Inspection when necessary.

Requirements

• Bachelor’s degree in science or related field to meet FDA requirements for sign offs.
• 2+ years of quality experience.
• Knowledge and understanding of quality principles and cGMP compliance in a manufacturing environment.
• Working knowledge of various testing apparatus beneficial.
• Detail oriented and well organized; strong math, writing, and reasoning skills.
• Self-starter with ability to work and think independently.
• Effective communication and interpersonal relationship skills.
• Proficiency in Microsoft Office: Word and Excel.
• Writing skills with the ability to create procedures, packaging instructions/specifications, cGMP documentation.
• Ability to interact and impact quality on the manufacturing floor and support customer requirements.

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.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401K
• Profit-sharing when we succeed as a team

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees