Inspector I 1st Shift

About the Role

This is an onsite, entry-level Manufacturing Quality (MQ) Inspector position located at our Dublin, Ohio plant. The role is responsible for monitoring production processes for compliance to cGMP standards and performing quality control checks to ensure appropriate utilization of equipment, commodities, product, and procedures.

Responsibilities

• 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.
• Monitor production lines for irregularities and report to area supervisor.
• Work with both internal and external customers, sharing information and providing feedback on material, operational, and mechanical-related issues.
• Perform mathematical calculations (adding, subtracting, multiplying, dividing) and work with fractions, decimals, and percentages.
• Use problem-solving and interpersonal skills for effective communication.
• 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, and clean work environment.
• Report all accidents to the supervisor and ensure proper use of PPE (personal protective equipment).
• Adhere to cGMP guidelines, SOPs, and plant policies.
• Assist in monitoring the area for cGMP compliance.
• Perform other related duties or special assignments as directed by supervisor.

Requirements

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

Qualifications

• 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.

Work Environment

• Work is performed in a cleanroom environment.
• May require sitting or standing for long periods of time.
• Must be able to occasionally move and lift objects of up to 25 lbs.
• Typically requires travel less than 5% of the time.
• Non-compliance with government regulations (FDA, GMP, etc.) can negatively impact the organization with adverse audit observations.

About Us

ICU Medical is 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. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we provide consistent quality, innovation, and value in more areas than ever. Our focus includes dedicated and non-dedicated IV sets, needle-free connectors, IV smart pumps, and IV medication safety software.