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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
If assigned to the filling/pouching/packing departments: Perform scheduled line checks which include verifying the correct filling equipment and production supplies are being used, the filling equipment is assembled correctly, 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 confirm that the equipment is passing/failing batch information and product properly
If assigned to the plastics department: 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
Make minor operational decisions and provide direction and guidance in the absence of the Quality Associate
Train and act as a resource to other Quality Inspectors
Participate on teams to drive improvement to processes and equipment
Assist in investigations of exceptions and any out of limits situations that may occur
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
Notify 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
Must have basic English written and oral communication skills adequate to communicate with other team members
Minimum 2 years of experience in a Quality role in a FDA regulated industry
Possess basic competency with the Microsoft Office Suite (Excel, Word, PowerPoint, etc.)
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 use of measurement tools (Caliper, Micrometer, Ruler, etc.) as well as basic hand tools
Possess or be able to obtain Work saver Operator Certification
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave