Associate III, Quality Compliance Job at Baxter (Mountain Home)

Associate III, Quality Compliance

This role is responsible for managing compliance areas, including Training, Docu...

Location

United States , Mountain Home

Salary:

96000.00 - 120000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum bachelor’s degree, preferably in Science or Engineering
equivalent experience will be considered
5+ years of experience in a quality or operational role
1-2 years in a supervisory/managerial position
Strong interpersonal skills for interactions with suppliers, QA Manager, Production Manager, and Corporate/Divisional groups
Regular and occasional communication with internal and external audit groups, TÜV, and end users
May require overtime, including nights and weekends
Use of hands/fingers to manipulate office equipment
Standing/walking for extended periods
Safety-sensitive position under Arkansas Medical Marijuana Amendment

Job Responsibility

Direct and supervise compliance departments including Training, Document Control, Critical Systems, and Calibrations
Ensure compliance of manufacturing and quality control operations with corporate specifications, SOPs, GMP/QSR (21CFR 820), ISO 13485, EN ISO 13485
Perform administrative functions in AS400 Document Control and Exception Menu, PRN and CDR programs
Act as Site SME for BaxU and TCU
Determine suitability of changes based on process, product, and regulatory knowledge
Coordinate activities of a section/department in the Quality Compliance organization
Participate in or manage quality assessments of suppliers
Manage mentoring, training, and development of subordinates
Assist in the development of departmental budget
Initiate action to prevent nonconformities and identify product/process/system problems

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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Associate III

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

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

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 starting 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 III

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master’s degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

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
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Quality Associate III

As a Quality Associate III – QC Microbiology, you will support microbiological q...

Location

United States of America , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

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
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Quality Associate III

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

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

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

Associate III Design Quality

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

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Having a good knowledge of injectable formulation - peptide/liposomes and complex generic molecules
Having a good knowledge of product development and life cycle management
Having a good knowledge of critical analytical techniques like LCMS, GCMS, HPLC, GC, IC etc
Having a good knowledge of regulatory requirements for ANDA/NDA submissions
Having good experience of responding regulatory queries
Having good critical thinking ability to challenge and resolve the technical concerns related to submission studies

Job Responsibility

To participate in meetings with cross functional teams like Analytical, Regulatory, Quality, manufacturing, Contract Manufacturing Organization (CMO), Project management, Characterization team for on time review support
To participate in meetings with Contract Manufacturing Organizations (CMOs) & Contract Research Organizations (CROs) & contract Labs for on-time review support
Responsible for tech transfer meetings with External Site as a core team member from quality for analytical discussion
To review, approve and ensure Technology Transfer/Validation/Verification/Post- production studies documents to respective plants
To be a part of investigations and to perform investigations extensively to derive root cause and its corrective measures and preventive actions
Quality SME for risk analysis of GPRD studies
To review and approve change controls, NCR/SNCR, CAPA, Effectiveness checks, etc
To carry out internal quality audits and perform GEMBA walks of R&D labs for compliance & betterment as per current regulations and GLP (Good Laboratory Practice)
To impart training to R&D team members on various aspects of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) guidelines and practices
To ensure that the development is carried out as per the latest QBD (Quality by Design) and PDLM concepts

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Quality Engineer Associate III

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

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Science or Engineering required
5 or more years experience in IT, Engineering, Science or related field
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Strong technical writing skills
Strong technical, analytical and problem solving skills
Good interpersonal, communication, influencing, negotiation skills
Understand scientific strategies and be able to invent new methods or new avenues of investigation
Good project management skills

Job Responsibility

Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities
Drive root cause problem solving for non-conformances in area of responsibility, and champion problems solving on the manufacturing floor
Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation
Manage activities in achieving defined quality goals in an efficient, accurate and timely manner
Ensure business needs and timeliness requirements of the department are met or exceeded
Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
Partners with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
Demonstrate leadership ability and be recognized by all levels of the facility as a subject matter expert in their area
Assists and writes validations, audits and assessments

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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Lab Associate III - Investigations

The MO Investigator leads the investigation of microbial out of limits that occu...

Location

United States , Marion

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor or Master’s degree in science, preferably in Microbiology, with minimum 2 years of experience conducting root cause investigations in the pharmaceutical/medical products industry
Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality
Strong communication and project management skills
Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC)
Must have strong technical writing skills and able to put complex thoughts and issues into writing in such a manner that can be understood by the reader
Must be able to interact with, and influence others at various levels in multiple departments
Must have knowledge of FDA quality systems regulations
Must have working knowledge of TrackWise system

Job Responsibility

Determines scope, product impact, root cause, corrective and/or preventive actions
Assembles cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
Closes investigations in a timely manner to meet business and compliance needs
Works with minimal supervision to drive investigations to closure
Works with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
Manages investigation and CAPA documentation in TrackWise in compliance with Baxter practices and procedures
Understands and implements procedures that support implementation of CAPAs
Presents and defends investigations during regulatory inspections, as required

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

Fulltime

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Associate III, Quality Compliance

Job Description

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What we offer

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