Quality Technician II

ITW•Olathe, KS

About The Position

Summary: Quality Technician II is an experienced quality professional responsible for independently executing advanced Quality Control and Quality Assurance activities in support of manufacturing operations and the company Quality Management System. This role supports compliance with applicable regulatory and quality standards including, but not limited to, ISO 9001, AS9100, and FDA cGMP requirements. In addition to routine inspection and testing, Quality Technician II serves as a technical resource for production teams, leads defined quality investigations, supports audits, and contributes to continuous improvement initiatives. This position requires minimal supervision and a strong understanding of manufacturing processes, documentation control, and regulatory expectations. Essential Duties: Independently inspect, test, and accept or reject raw materials, intermediaries, and finished products using written specifications, as established by company procedures. Work closely with Manufacturing Work Cells and other Quality Technicians to maintain production/product testing schedules. Review Production Records to check the accuracy of data entered by production personnel such as batch yields, label counts, raw materials additions etc. Review receiving documentation for shipments including components, chemical raw materials, bulk raw materials, and finished goods: and if necessary then analyze samples before approval. Perform final approval of regulated batch records and master batch record updates. Assist in maintaining the Quality documentation system. Closing of batch tickets and issuing of Certificates of Analysis. Record data in quality logs, software package, and maintain accurate records in accordance with GMP good documentation practices. Report production issues to Quality Manager and ask for guidance on next steps. Work in conjunction with operations and R&D teams, troubleshoot quality concerns that may arise on the production floor, and are beyond of Quality Control duties. Perform production line checks and proactively identify potential quality or compliance issues. Maintenance of finished goods and raw material retains; manage purge and disposal activities according to retention requirements. Provide writing reports and fill up forms when participating in identifying, investigating, and processing Corrective/Preventive Actions, Customer Complaints, product Non-Conformance, Deviations, Quality Alerts, and 48 hrs. Returned Goods Authorizations. Maintenance and housekeeping of laboratory testing equipment and surrounding areas in the lab by practicing 5S. Update and distribute documentation to production personnel. Participate in production pre-shift meetings and keep informed about changes in production schedule. Testing of customer samples. Assists with audits as needed. Assists with equipment calibration schedule. May be required, as needed, to work overtime, weekends or alternate shifts to support production. Follow all safety rules and take a leadership role in ensuring a safe environment. Assist in writing, editing, and training of standard operating procedures as needed. Supports Operations team to ensure quality standards. Follows the 80/20 philosophy in prioritizing daily tasks and serves as a contributing member of the Technical Operations Staff. Professional represents company in a number of diverse settings including active participation in required audits and other related meetings. Foster, communicate and exemplify the values of ITW; act with integrity and trust, operate with simplicity, treat everyone with respect, take shared risk. Performs other duties as assigned.

Requirements

Minimum of a high school diploma or equivalent. College or Technical School education in the sciences or technical related areas such as quality, regulatory a plus.
Minimum of 3-5 years’ work experience as a Quality Technician or related position.
Demonstrated experience working in a facility regulated by FDA, cGMP, AS9100 and ISO9001.
Must be familiar with reading and following Standard Operating Procedures for production and laboratory processes.
Must be organized and able to handle multiple tasks daily.
Must be flexible to change.
Must be reliable and capable of carrying out responsibilities with minimal supervision.
Must be able to work in teams and individually.
Proficient in Microsoft Office programs (Word, Excel, Power Point) and Outlook.
Strong written, verbal and collaborative communication skills.
Excellent interpersonal, written, and verbal communication skills.
Must be detailed oriented.
Proficient time management and prioritization skills.
Must have good computer skills and knowledge of Microsoft Office (Word, Excel, Outlook).
Must be motivated to grow and develop skills for advancement.
Ability to work independently with minimal supervision.
Ability to work in a demanding, fast-paced environment.
Ability to calculate mathematical values.
Must be able to work cross-functionally with other departments.
Able to adapt to changes in the work environment; able to deal with frequent change, delays, or unexpected events.
Able to understand manufacturing processes / procedures and product applications.
Must be dependable, have excellent attendance and be punctual.
Able to work overtime when required.
Must be able to interpret documents such as operating instructions, safety rules, and procedure manuals.
Must be able to handle multiple tasks simultaneously, manage priorities and work independently as well as on a team.
Well-developed emotional quotient, able to relate well to people at all levels inside and outside the organization such as operators, executives, suppliers, customers, etc.
Commitment and willingness to strive toward achieving goals and business objectives.
Acts with a sense of urgency to drive results.
Possess an entrepreneurial spirit and willing to take initiative with focus on the key initiatives and opportunities for improvement and growth.
Self-starter, highly motivated, follows directions well and can work with little or no supervision.
Able to effectively work with and through others in a collaborative environment.
Takes ownership and drives positive change.

Nice To Haves

College or Technical School education in the sciences or technical related areas such as quality, regulatory a plus.
Quality Technician experience in a chemical manufacturing facility a plus.
Experience in conducting basic laboratory tests such as pH, viscosity, specific gravity, etc.

Responsibilities

Independently inspect, test, and accept or reject raw materials, intermediaries, and finished products using written specifications, as established by company procedures.
Work closely with Manufacturing Work Cells and other Quality Technicians to maintain production/product testing schedules.
Review Production Records to check the accuracy of data entered by production personnel such as batch yields, label counts, raw materials additions etc.
Review receiving documentation for shipments including components, chemical raw materials, bulk raw materials, and finished goods: and if necessary then analyze samples before approval.
Perform final approval of regulated batch records and master batch record updates.
Assist in maintaining the Quality documentation system.
Closing of batch tickets and issuing of Certificates of Analysis.
Record data in quality logs, software package, and maintain accurate records in accordance with GMP good documentation practices.
Report production issues to Quality Manager and ask for guidance on next steps.
Work in conjunction with operations and R&D teams, troubleshoot quality concerns that may arise on the production floor, and are beyond of Quality Control duties.
Perform production line checks and proactively identify potential quality or compliance issues.
Maintenance of finished goods and raw material retains; manage purge and disposal activities according to retention requirements.
Provide writing reports and fill up forms when participating in identifying, investigating, and processing Corrective/Preventive Actions, Customer Complaints, product Non-Conformance, Deviations, Quality Alerts, and 48 hrs. Returned Goods Authorizations.
Maintenance and housekeeping of laboratory testing equipment and surrounding areas in the lab by practicing 5S.
Update and distribute documentation to production personnel.
Participate in production pre-shift meetings and keep informed about changes in production schedule.
Testing of customer samples.
Assists with audits as needed.
Assists with equipment calibration schedule.
May be required, as needed, to work overtime, weekends or alternate shifts to support production.
Follow all safety rules and take a leadership role in ensuring a safe environment.
Assist in writing, editing, and training of standard operating procedures as needed.
Supports Operations team to ensure quality standards.
Follows the 80/20 philosophy in prioritizing daily tasks and serves as a contributing member of the Technical Operations Staff.
Professional represents company in a number of diverse settings including active participation in required audits and other related meetings.
Foster, communicate and exemplify the values of ITW; act with integrity and trust, operate with simplicity, treat everyone with respect, take shared risk.
Performs other duties as assigned.