Associate II, Quality Job at Baxter (Marion)

Associate II, Quality (7pm-7am)

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Marion

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent required
Must be at least 18 years of age
BS in engineering/science or equivalent work experience
3-5 years exp. 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

Job Responsibility

Leads ongoing, daily departmental operations
May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner
Interview/hire, evaluate, train and develop direct reports
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions
Determine the logic, adequacy and effectiveness of processes, systems and related requirements
Develop plans to correct identified risks including areas of non-conformance
Inform management and implement approved corrective action plans
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements
Provide training and coaching to local employees and others as needed on relevant area(s)

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

Fulltime

Associate II, Quality (7pm-7am)

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Marion

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent required. Must be at least 18 years of age
BS in engineering/science or equivalent work experience
3-5 years exp. 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

Job Responsibility

Leads ongoing, daily departmental operations
May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner
Interview/hire, evaluate, train and develop direct reports
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions
Determine the logic, adequacy and effectiveness of processes, systems and related requirements
Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s)
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items

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
Paid Time Off

Fulltime

Associate Ii Quality

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Marion

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

High School Diploma, GED, or equivalent required. Must be at least 18 years of age.
BS in engineering/science or equivalent work experience.
3-5 years exp. 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.

Job Responsibility

Leads ongoing, daily departmental operations.
May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner
Interview/hire, evaluate, train and develop direct reports
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions.
Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
Develop plans to correct identified risks including areas of non-conformance. Inform management and implement approved corrective action plans.
Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed on relevant area(s). When required, assist other Quality areas in the successful performance of these activities.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items.

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
Paid Time Off

Fulltime

Associate II, Quality Lab - Group Leader

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Marion

Salary:

68000.00 - 93500.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Sciences: Biology or Microbiology preferred
Minimum 3 years experience in a Quality Control Laboratory, Environmental Monitoring Lab, or Microbiology Lab
Solid understanding of Environmental Monitoring
Computer literate/knowledge of Microsoft office applications (Word, Excel)
Attention to detail and strong organizational skills
Must have advanced understanding of laboratory instrumentation
Good documentation skills and knowledge of GDPs (Good Documentation Practices)
Exhibits writing and document review proficiency
Able to handle multiple tasks/priorities
Strong knowledge of BLAS, BAxLIMS (or equivalent lab system) and TrackWise

Job Responsibility

Perform Environmental Monitoring tests such as surfaces, viable air, non-viable air, air pressures, etc.
Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
Follow laboratory safety procedures to ensure compliance or to make improvements as needed
Monitor operational procedures in technical environments to ensure conformance to standards
Operate lab equipment such as SAS machines, CLIMETs, etc.
Review samples received, logs samples, and enter data into computer database
Responsible for general housekeeping of laboratory and test suites
Sustain a clean and safe work environment applying 6S principles
Perform routine laboratory and safety audits
Serve as mentor to Quality Laboratory Associate (QLA) I and II positions

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

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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

Quality Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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

Quality associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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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Associate II, Quality

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