Manufacturing Quality Inspector - 3rd Shift

Otsuka ICU Medical; Austin (TX); On-site; USD 42,000 - 62,000; Full time

Job summary

Otsuka ICU Medical is seeking a Manufacturing Quality Inspector for the 3rd shift (Sun-Wed, 6:00pm-4:30am) to monitor production lines in a clean-room environment and ensure adherence to cGMP standards. The role requires inspecting materials, batch records, and finished products, performing functional and dimensional tests, and documenting results.

Candidates should be detail-oriented, able to work independently and in teams, and have at least a High School Diploma with 1 year of

Qualifications

• Must pass written and practical area requirements for area/certification.
• Must be able to read, understand, and communicate well with others in person and over the phone.
• Must have working knowledge of mathematical calculations (adding, subtracting, multiplying, dividing).
• Capable of working with fractions, decimals, and percentages.
• Must be able to input data into a computer, as required.
• Must be able to work independently and in a team environment.

Responsibilities

• Inspects materials, batch record documents and final products during the production process or offline.
• Performs and records release functional and dimensional testing.
• Restarts automated equipment that stopped for quality issues.
• Evaluates products for defects and recognizes unacceptable product.
• Makes decisions regarding product conformity and determines if MQ batch record criteria is met.
• Collects file samples, stability testing samples, and laboratory samples.
• Inputs data into batch records, reports and electronic databases.
• Monitors production lines for irregularities and reports to supervisor.

Skills

Attention to detail

Mathematical calculations

Independent work

Team collaboration

Data entry

Equipment handling

Problem solving

Communication

Education

High School Diploma

Tools

Laboratory equipment

Job description

Otsuka ICU Medical is seeking a Manufacturing Quality Inspector for the 3rd shift (Sun-Wed, 6:00pm-4:30am) to monitor production lines in a clean-room environment and ensure adherence to cGMP standards. The role requires inspecting materials, batch records, and finished products, performing functional and dimensional tests, and documenting results.

Candidates should be detail-oriented, able to work independently and in teams, and have at least a High School Diploma with 1 year of