Manufacturing Quality Inspector I

Otsuka ICU Medical•Austin, TX

2h•Onsite

About The Position

The Manufacturing Quality Inspector monitors production processes for compliance with current Good Manufacturing Practice (cGMP) standards. The role performs quality-control checks to ensure appropriate use of equipment, commodities, products, and procedures in the assigned production area. It conducts and documents visual, functional, and dimensional testing to support commodity and product release, particularly in bag fabrication, overwrap, and packaging. The inspector evaluates materials, batch-record documentation, and products during production and offline activities; conducts release testing; assesses product conformity against specifications and batch-record criteria; collects samples; records data; and monitors production lines for irregularities. The role also supports communication with internal and external customers, maintains a safe and clean work environment, follows gowning and PPE requirements, and adheres to cGMP, SOPs, and plant policies. Work is performed in a clean-room environment and may affect QA goals and documentation compliance.

Requirements

Must be at least 18 years of age.
High school diploma required.
At least one year of experience as a production operator or in similar production or quality work.
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 by phone.
Working knowledge of mathematical calculations, including fractions, decimals, and percentages.
Ability to input data into a computer as required.
Good mechanical skills for handling laboratory equipment.
Ability to work independently and in a team environment; dependability, competence, and good attendance.
Detail-oriented, with strong focus to detect irregularities in in-process work.
Ability to adapt positively to a changing environment or situation.
Ability to maintain confidentiality of personal and business information.
Ability to function independently with minimal supervision.

Nice To Haves

Back-up specialist or Specialist experience.

Responsibilities

Inspect materials, batch-record documents, and final products during production and offline activities, including APQR, re-inspection, and batch records.
Perform and record release functional and dimensional testing.
Restart automated equipment that has stopped due to quality issues.
Evaluate products for defects, recognize unacceptable products, determine product conformity, and decide whether MQ batch-record criteria are met.
Test commodities and final products and determine acceptance according to specifications.
Collect file, stability-testing, and laboratory samples in accordance with established procedures.
Enter numerical and informational data into batch records, reports, and electronic databases.
Monitor production lines for irregularities and report them to the area supervisor.
Work with internal and external customers, share information, and provide feedback on material, operational, and mechanical issues.
Perform mathematical calculations, including addition, subtraction, multiplication, and division.
Use problem-solving and interpersonal skills to communicate effectively, follow up on activities, and help maintain quality.
Assist with area improvements, department changes, and meetings.
Follow uniform and gowning requirements and maintain a safe, orderly, clean work environment.
Report accidents to the supervisor and use required personal protective equipment.
Adhere to cGMP guidelines, SOPs, and plant policies and guidelines; assist in monitoring the area for cGMP compliance.
Perform other related duties or special assignments as directed by the supervisor.