About the position
The Quality Assurance Inspector is a Salaried Non-Exempt position which contributes to our mission of saving and sustaining lives by ensuring our products and packaging meet exacting quality standards through a variety of sampling, testing and analytical processes. Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
Responsibilities
- Perform scheduled line checks which include verifying the accurate filling equipment and production supplies are being used, the filling equipment is assembled accurately, the settings are appropriate and the batch signage is correct.
- Collect samples and verify container, components and over-pouch meet quality standards, verify the accuracy & legibility of the print and check for indications of leakage.
- Examine and verify that the packaging equipment's performance meets quality standards.
- Test and prove that the equipment is passing/failing batch information and product properly.
- Collect samples of produced materials (i.e. membranes, bags, tubing, frangibles) and visually inspect for irregularities and verify dimensions are within specification.
- Perform seal integrity testing on a sample of produced materials.
- Employ various methods of testing such as freeze mode, destructive oven testing and striation testing.
- Examine and verify that documentation meets requirements.
- Transport samples to and from work area with a Powered Industrial Truck (PIT).
- Document and initiate the exception process if exception is encountered using the Production Operations Management System (POMS) to research and provide details.
- Record checks and the result into POMS.
- Write and submit changes to a Standard Operating Procedure (SOP) document when a process used by the QA Inspector is in need of an update.
- Enter exception data into a spreadsheet for trending and reporting purposes.
- Participate in the validation process for new equipment, equipment changes and new processes by performing product testing and reporting on the results.
- Calibrate gauges, rulers, cylinders when necessary using blueprints and calibration equipment.
- May be designated as a Subject Matter Expert (SME) on an assigned SOP.
- Advise the supervisor and take appropriate action if any safety, quality or discrepancy issues occur.
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).
- Sustain a clean and safe work area using 6S principles including maintaining and securing provided tools.
Requirements
- High School Diploma, GED or equivalent.
- Must be at least 18 years of age.
- QT Certification or Workkeys proficiency tests (CRC) with minimum scores of: Level 4 in mathematics, Level 4 in locating information and Level 4 in reading.
- Must have basic English written and oral communication skills adequate to communicate with other team members.
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Must be able to perform basic mathematics.
- Proficient in how to use measurement tools (Caliper, Micrometer, Ruler, etc.) as well as basic hand tools.
- Possess or be able to obtain Worksaver Operator Certification.
Benefits
- Medical, Dental and Vision coverage
- 160 hours of Paid Time Off and Paid Holidays
- 401K match
- Employee Stock Purchase Program
- Paid Parental Leave
- Tuition Reimbursement
