Inspector I 2nd Shift

About the role

The Manufacturing Quality (MQ) Inspector’s responsibility will be to monitor production processes for compliance to cGMP standards. They will perform a variety of quality control checks to ensure appropriate utilization of equipment, commodities, product and procedures for the assigned production area.

Responsibilities

• Inspects materials, batch record documents and final products during the production process or off line (APQR, re-inspection, batch records).
• Performs and records release functional and dimensional testing.
• Restarts automated equipment that stopped for quality issues.
• Evaluates products for defects and recognize unacceptable product.
• Makes decision regarding product conformity and determines if MQ batch record criteria is met.
• Performs testing on commodities and final product and determines acceptance according to specifications.
• Collections file samples, stability testing samples, and laboratory samples in accordance with established procedures.
• Inputs data (numerical/informational) into batch records, reports and electronic data bases.
• Recognizes unacceptable product.
• Makes decisions regarding product conformity and determines if MQ batch record criteria is met.
• Monitors production lines for irregularities and reports to area supervisor, accordingly.
• Works with both internal and external customers. Shares information and provides feedback on material, operational, and mechanical related issues.
• Performs mathematical calculations such as adding, subtracting, multiplying and dividing and therefore must have working knowledge of mathematical applications.
• Uses good problem solving and interpersonal skills for effective communications.
• Follows up on activities to ensure quality is maintained.
• Aids in area improvements, department changes and meetings.
• Follows prescribed uniform and gowning requirements.
• Maintains a safe, orderly, clean work environment.
• Reports all accidents to the supervisor.
• Ensures all PPE (personal protective equipment) is used, as required.
• Adheres to cGMP guidelines, SOP’s and plant policies/guidelines.
• Aids in monitoring area for cGMP compliance.
• Perform other related duties or special assignments as directed by supervisor.

Qualifications

• Must pass written and practical area requirements for area/certification.
• Must have the ability to follow verbal and written instructions and read, understand, and communicate well with others in person and over the phone.
• Must have a working knowledge of mathematical calculations, such as adding, subtracting, multiplying, and dividing. Capable of working with fractions, decimals, and percentages.
• Must be able to input data into a computer, as required.
• Possesses good mechanical skills to handle lab equipment.
• Must be able to work independently and in a team environment.
• Must be dependable, competent and show good attendance.
• Must be a detail-oriented person. Requires strong focusing skills on in-process work activities to detect irregularities.
• Adapts positively to a changing environment and/or situation.
• Must be able to maintain confidentiality with personal and business information.
• The incumbent will be expected to function independently with minimum supervision.

Requirements

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

Skills

• Must pass written and practical area requirements for area/certification.
• Must have the ability to follow verbal and written instructions and read, understand, and communicate well with others in person and over the phone.
• Must have a working knowledge of mathematical calculations, such as adding, subtracting, multiplying, and dividing. Capable of working with fractions, decimals, and percentages.
• Must be able to input data into a computer, as required.
• Possesses good mechanical skills to handle lab equipment.
• Must be able to work independently and in a team environment.
• Must be dependable, competent and show good attendance.
• Must be a detail-oriented person. Requires strong focusing skills on in-process work activities to detect irregularities.
• Adapts positively to a changing environment and/or situation.
• Must be able to maintain confidentiality with personal and business information.

About ICU Medical

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now 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're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever.

The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

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