Inspector, Manufacturing ​/ Production, Quality Technician​/ Inspector

Overview

The Manufacturing Quality (MQ) Inspector’s responsibility is to monitor production processes for compliance with cGMP standards. The inspector will perform quality control checks to ensure proper utilization of equipment, commodities, product and procedures for the assigned production area. Conduct and document visual, functional and dimensional testing in support of commodity/product release – particularly in the bag fabrication, overwrap and packaging areas of production.

• Inspect materials, batch record documents and final products during the production process or offline (APQR, re-inspection, batch records). Perform and record release functional and dimensional testing. Restart automated equipment that stopped for quality issues.
• Evaluate products for defects and recognize unacceptable product. Make decisions regarding product conformity and determine if MQ batch record criteria are met.
• Perform testing on commodities and final product and determine acceptance according to specifications.
• Collect file samples, stability testing samples, and laboratory samples in accordance with established procedures.
• Input data (numerical/informational) into batch records, reports and electronic databases. Recognize unacceptable product. Monitor production lines for irregularities and report to area supervisor accordingly.
• Work with internal and external customers. Share information and provide feedback on material, operational, and mechanical related issues.
• Perform mathematical calculations (addition, subtraction, multiplication and division) and maintain working knowledge of mathematical applications.
• Use problem solving and interpersonal skills for effective communications. Follow up on activities to ensure quality is maintained. Assist in area improvements, department changes and meetings.
• Follow prescribed uniform and gowning requirements. Maintain a safe, orderly, clean work environment. Report all accidents to the supervisor. Ensure all PPE is used, as required.
• Adhere to cGMP guidelines, SOPs and plant policies/guidelines. Assist in monitoring area for cGMP compliance.
• Perform other related duties or special assignments as directed by supervisor.

• Must pass written and practical area requirements for area/certification.
• Ability to follow verbal and written instructions and read, understand, and communicate well in person and over the phone.
• Working knowledge of mathematical calculations (adding, subtracting, multiplying, and dividing). Capable of working with fractions, decimals, and percentages. Ability to input data into a computer as required.
• Possesses good mechanical skills to handle lab equipment.
• Ability to work independently and in a team environment. Dependable, competent and good attendance.
• Detail-oriented with strong focusing skills on in-process work activities to detect irregularities.
• Adaptable to a changing environment and/or situation.
• Ability to maintain confidentiality with personal and business information.
• Function independently with minimum supervision.

• Must be at least 18 years of age.
• High School Diploma required.
• Minimum one year of experience as a production operator or similar production or quality experience.

• The MQ Inspector position can directly impact the QA organization relative to business goals and documentation compliance. Non-compliance with government regulations (FDA, GMP, etc.) can negatively impact the organization with adverse audit observations.
• Work is performed in a clean room environment.
• May be required to sit or stand for long periods of time.
• Must be able to occasionally move and lift objects up to 25 lbs.
• Typically requires travel less than 5% of the time.

ICU Medical has consistently provided clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. We are focused on delivering…