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Baxter Logo Baxter · Quality Control

Quality Associate II

United States, Marion Employment contract 88000.00 - 121000.00 USD / Year · Job Posted June 28, 2026
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Job Description

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

  • Serve as an SME for trending, Management Review, local and corporate metrics, APQR, and other systems involving metrics
  • Complete trending, APQR, and Management review process objectives
  • Utilize knowledge of software to compile and interpret data, and work with statistical and trending software to analyze data
  • Ensure compliance with all applicable SME-related Standard Operating Procedures (SOPs)
  • Participate in FDA inspections, preparing materials and interfacing directly with FDA
  • Ensure audit readiness of the area by researching background information, maintaining current and in alignment with procedures, and reviewing related audit results
  • Remain current in industry and regulatory trends in this SME area through attendance at related conferences, seminars, meetings, and other training methods
  • Participate in the development and delivery of GxP training programs, as needed
  • Work closely with production supervisors, quality, engineering, and other internal groups to accomplish the above and influence necessary actions
  • Write, review, analyze, and revise written Standard Operating Procedures (SOPs) to meet regulatory, corporate, and plant requirements
  • Support and participate with management during external inspections, as needed
  • Maintain a clean and safe work area using 6S principles
  • Perform other duties, tasks, or projects, as assigned

Requirements

  • High School Diploma, GED, or equivalent required. Must be at least 18 years of age
  • BS in engineering/science or equivalent work experience
  • Multiple years of experience in Quality with a medical device/Pharma company or other similarly regulated industry
  • Strong interpersonal skills and great attention to detail are necessary
  • Must be a strong team player with good problem solving, and good verbal and written communication skills
  • Must have the ability to manage people, encourage teamwork and drive decisions
  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
  • Must have basic English written and oral communication skills adequate to communicate with other team members

What we offer

  • 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
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • 2 Days a Year to Volunteer
  • Flexible Spending Accounts
  • educational assistance programs
  • commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • childcare benefits
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
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Quality Associate II

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Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Round Lake
Salary
Salary:
88000.00 - 121000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in business/science or equivalent degree
  • 3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
  • Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
  • Strong interpersonal skills and great attention to detail are necessary
  • Must be a team player with good problem solving, and good verbal and written communication skills
  • Must be able to handle multiple projects concurrently
  • Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
  • Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • Knowledge of and experience with outside the US regulatory requirements is desirable
  • A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
Job Responsibility
Job Responsibility
  • Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System
  • Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements
  • Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required
  • Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes
  • Prepares and publishes annual product reviews
  • Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
  • Schedules and plans for the audit activity by researching background information, including previous audit results
  • Plans and develops assessment strategy and logistics
  • Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks
  • Reports findings (verbally and written) to management
What we offer
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
  • Fulltime
Read More
Arrow Right

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Round Lake
Salary
Salary:
88000.00 - 121000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in business/science or equivalent degree
  • 3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
  • Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
  • Strong interpersonal skills and great attention to detail are necessary
  • Must be a team player with good problem solving, and good verbal and written communication skills
  • Must be able to handle multiple projects concurrently
  • Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
  • Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • Knowledge of and experience with outside the US regulatory requirements is desirable
  • A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
Job Responsibility
Job Responsibility
  • Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System
  • Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements
  • Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required
  • Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes
  • Prepares and publishes annual product reviews
  • Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
  • Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
  • Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
  • Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
  • Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
What we offer
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
  • Basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
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Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Round Lake
Salary
Salary:
88000.00 - 121000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in business/science or equivalent degree
  • 3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
  • Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
  • Strong interpersonal skills and great attention to detail are necessary
  • Must be a team player with good problem solving, and good verbal and written communication skills
  • Must be able to handle multiple projects concurrently
  • Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
  • Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • Knowledge of and experience with outside the US regulatory requirements is desirable
  • A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
Job Responsibility
Job Responsibility
  • Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
  • Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
  • Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
  • Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
  • Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
  • Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective
  • Trains and mentors new auditors and manages the guest auditor program
  • Supports management of external inspections. Tracks and reports the status of external commitments through closure
  • Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure
  • Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects
What we offer
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
  • Fulltime
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Arrow Right

Quality associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Round Lake
Salary
Salary:
88000.00 - 121000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS in business/science or equivalent degree
  • 3 or more years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry
  • Previous auditing experience required, and ASQ and/or other accreditation is highly desirable
  • Strong interpersonal skills and great attention to detail are necessary
  • Must be a team player with good problem solving, and good verbal and written communication skills
  • Must be able to handle multiple projects concurrently
  • Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable
  • Must have knowledge of and experience with FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
  • A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials
  • Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time
Job Responsibility
Job Responsibility
  • Primary responsibility for the execution and management of the internal audit process at Round Lake Drug Delivery ensuring compliance with all applicable provisions of Baxter’s Quality System, and the regulations and standards applicable to RLDD operations
  • Schedules and plans for the audit activity by researching background information, including previous audit results. Plans and develops assessment strategy and logistics
  • Performs internal audits, either individually or as a team lead/participant, by collecting and analyzing objective evidence regarding issues and risks. Reports findings (verbally and written) to management
  • Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure
  • Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes
  • Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective
  • Trains and mentors new auditors and manages the guest auditor program
  • Supports management of external inspections. Tracks and reports the status of external commitments through closure
  • Schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Documents and tracks action items and follow-up commitments to closure
  • Leads and manages multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects
What we offer
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
  • Fulltime
Read More
Arrow Right

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Mountain Home
Salary
Salary:
88000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum associate’s degree required
  • Bachelor’s of Science strongly preferred
  • At least 5 years of operations or quality experience, with leadership experience highly preferred
  • Ability to generate reports, trend performance, and perform data analysis for quality systems
  • Strong interpersonal communication and leadership skills
  • Self-motivated with the ability to handle a variety of tasks
  • Reliable attendance is essential, with the possibility of overtime work, including nights and weekends
  • Ability to use hands and fingers to manipulate office equipment
  • Capability to stand and walk for extended periods
  • Ability to lift up to 40 lbs
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  • Possess detailed knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, and in-process and final release requirements
  • Demonstrate excellent communication skills, both written and spoken, for presentations, classroom instruction, and generating reports, memos, and project status updates
  • Apply direct technical and organizational management skills to initiate, implement, complete, and sustain subordinate activities and behaviors
  • Implement and ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, and Good Manufacturing Practices/Quality System Regulations
  • Take direct responsibility for the plant pest control program, including coordinating with pest control vendors and performing regular inspections and annual reports
  • Participate in or manage quality assessments of suppliers to analyze compliance and assess risk
  • Frequently interact with subordinate supervisors and functional peer group managers
  • Coordinate the plant calibration program, partnering with maintenance staff on calibrations and preparing monthly completion reports for management review
  • Coordinate the site visual inspection program and continuous process verification (CPV)
  • Engage directly with auditors regarding pest control, calibrations, visual inspection, critical systems, and CPV
What we offer
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
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  • Fulltime
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Arrow Right

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Mountain Home
Salary
Salary:
88000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum associate’s degree required
  • Bachelor’s of Science strongly preferred
  • At least 5 years of operations or quality experience, with leadership experience highly preferred
  • Ability to generate reports, trend performance, and perform data analysis for quality systems
  • Strong interpersonal communication and leadership skills
  • Self-motivated with the ability to handle a variety of tasks
  • Reliable attendance is essential, with the possibility of overtime work, including nights and weekends
  • Ability to use hands and fingers to manipulate office equipment
  • Capability to stand and walk for extended periods
  • Ability to lift up to 40 lbs
Job Responsibility
Job Responsibility
  • Possess detailed knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, and in-process and final release requirements
  • Demonstrate excellent communication skills, both written and spoken, for presentations, classroom instruction, and generating reports, memos, and project status updates
  • Apply direct technical and organizational management skills to initiate, implement, complete, and sustain subordinate activities and behaviors
  • Implement and ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, and Good Manufacturing Practices/Quality System Regulations
  • Take direct responsibility for the plant pest control program, including coordinating with pest control vendors and performing regular inspections and annual reports
  • Participate in or manage quality assessments of suppliers to analyze compliance and assess risk
  • Frequently interact with subordinate supervisors and functional peer group managers
  • Coordinate the plant calibration program, partnering with maintenance staff on calibrations and preparing monthly completion reports for management review
  • Coordinate the site visual inspection program and continuous process verification (CPV)
  • Engage directly with auditors regarding pest control, calibrations, visual inspection, critical systems, and CPV
What we offer
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
  • Fulltime
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Arrow Right

Quality Associate II

As a Quality Associate II, you will have the outstanding opportunity to lead all...
Location
Location
United States , Mountain Home
Salary
Salary:
88000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum associate’s degree required
  • Bachelor’s of Science strongly preferred
  • At least 5 years of operations or quality experience, with leadership experience highly preferred
  • Ability to generate reports, trend performance, and perform data analysis for quality systems
  • Strong interpersonal communication and leadership skills
  • Self-motivated with the ability to handle a variety of tasks
  • Reliable attendance is essential, with the possibility of overtime work, including nights and weekends
  • Ability to use hands and fingers to manipulate office equipment
  • Capability to stand and walk for extended periods
  • Ability to lift up to 40 lbs
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  • Possess detailed knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, and in-process and final release requirements
  • Demonstrate excellent communication skills, both written and spoken, for presentations, classroom instruction, and generating reports, memos, and project status updates
  • Apply direct technical and organizational management skills to initiate, implement, complete, and sustain subordinate activities and behaviors
  • Implement and ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, and Good Manufacturing Practices/Quality System Regulations
  • Take direct responsibility for the plant pest control program, including coordinating with pest control vendors and performing regular inspections and annual reports
  • Participate in or manage quality assessments of suppliers to analyze compliance and assess risk
  • Frequently interact with subordinate supervisors and functional peer group managers
  • Coordinate the plant calibration program, partnering with maintenance staff on calibrations and preparing monthly completion reports for management review
  • Coordinate the site visual inspection program and continuous process verification (CPV)
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  • 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
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Arrow Right

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...
Location
Location
United States , Mountain Home
Salary
Salary:
88000.00 - 110000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum associate’s degree required
  • Bachelor’s of Science strongly preferred
  • At least 5 years of operations or quality experience, with leadership experience highly preferred
  • Ability to generate reports, trend performance, and perform data analysis for quality systems
  • Strong interpersonal communication and leadership skills
  • Self-motivated with the ability to handle a variety of tasks
  • Reliable attendance is essential, with the possibility of overtime work, including nights and weekends
  • Ability to use hands and fingers to manipulate office equipment
  • Capability to stand and walk for extended periods
  • Ability to lift up to 40 lbs
Job Responsibility
Job Responsibility
  • Possess detailed knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, and in-process and final release requirements
  • Demonstrate excellent communication skills, both written and spoken, for presentations, classroom instruction, and generating reports, memos, and project status updates
  • Apply direct technical and organizational management skills to initiate, implement, complete, and sustain subordinate activities and behaviors
  • Implement and ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, and Good Manufacturing Practices/Quality System Regulations
  • Take direct responsibility for the plant pest control program, including coordinating with pest control vendors and performing regular inspections and annual reports
  • Participate in or manage quality assessments of suppliers to analyze compliance and assess risk
  • Frequently interact with subordinate supervisors and functional peer group managers
  • Coordinate the plant calibration program, partnering with maintenance staff on calibrations and preparing monthly completion reports for management review
  • Coordinate the site visual inspection program and continuous process verification (CPV)
  • Engage directly with auditors regarding pest control, calibrations, visual inspection, critical systems, and CPV
What we offer
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  • 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
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Arrow Right