Associate I, Quality Laboratory Job at Baxter (Round Lake)

Associate I, Quality Laboratory

The Quality Lab Associate I encompasses the biological, chemical and physical an...

Location

United States , Round Lake

Salary:

64000.00 - 88000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in chemistry or science related degree with 6 months or more of experience
Knowledge of Empower CDS and LIMS is preferred but not required
Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required
Excellent communication (oral and written) and interpersonal skills
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a highly dynamic environment
Ability to lift up to 50 pounds when required
Must not be color blind
20/20 vision with or without correction
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs
Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data
Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality
Perform laboratory and manufacturing audits as required
Audit and update, as required, plant SOPs
Perform equipment maintenance and calibrations as required
Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records
Follow, understand and comply with Baxter SOP’s and policies on cGMP’s and safety

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

Associate I, Quality Laboratory

The Quality Lab Associate I encompasses the biological, chemical and physical an...

Location

United States , Round Lake

Salary:

64000.00 - 88000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in chemistry or science related degree with 6 months or more of experience
Knowledge of Empower CDS and LIMS is preferred but not required
Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required
Excellent communication (oral and written) and interpersonal skills
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a highly dynamic environment
Ability to lift up to 50 pounds when required
Must not be color blind
20/20 vision with or without correction
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

Job Responsibility

Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at Baxter manufacturing facilities
Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data
Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality
Perform laboratory and manufacturing audits as required
Perform equipment maintenance and calibrations as required
Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records
Follow, understand and comply with Baxter SOP’s and policies on cGMP’s and safety
Investigate deviations and write exception/OOL/OOS/OOT documents

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

Sr. Associate I, Quality Control

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

To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias

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

Sr. Associate I, Quality Control

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

To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias

What we offer

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

Sr. Associate I, Quality Control

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

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Job Responsibility

To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / Laboratory error / deviation and take corrective and preventive actions
To ensure that preparation of reagents and volumetric solution and standardization on time
To perform periodic observation of retained sample
To initiate Change control (CcM), Non conformation report (NCR), Out of Specification (OOS), Document change record (DCR) etc.. QMS related documents
To do the work allocation in shift and ensure it complete within timeline
To assess the results of testing of In-process sample and finish products to ensure alignment with standard operating procedure (SOP) and regulatory guidelines
To review results of the tests against the specification & standard test procedure performed by team members
To investigate out of specification (OOS), Non-conformity and Laboratory Error Report (LER) related to In-Process Product Testing (IPPT) & Finished Product Testing (FP) and take corrective and preventive actions
To follow and ensure Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) inside QC
To ensure availability the working & impurities standards as per various pharmacopoeias

What we offer

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

New

R&D Quality Laboratory Oversight (Associate Director)

Be a key quality leader ensuring high-quality, compliant analytical testing acro...

Location

Japan , Kanagawa

Salary:

Not provided

BioLife Plasma Services

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field
MS/PhD preferred
7+ years' experience in GxP laboratory quality oversight (GMP/GLP, analytical testing, inspections)
Strong knowledge of analytical methods and lab operations for small molecules and biologics
Proven skills in data integrity, deviation/CAPA management, and quality risk management
Clear communicator and collaborator, effective in a global matrix environment with competing priorities

Job Responsibility

Provide quality oversight for GxP and non-GxP labs across the R&D pipeline
Review and approve critical GMP/GLP documentation (methods, validations, deviations, CAPAs)
Ensure robust ALCOA+ data integrity controls in lab systems, processes, and records
Lead or support lab-related investigations, audits, and inspections with clear, timely CAPA
Collaborate with Pharmaceutical Sciences, Regulatory, Manufacturing, and QA to align on quality expectations

What we offer

Allowances: Commutation, Housing, Overtime Work
Salary Increase: Annually, Bonus Payment: Twice a year
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Fulltime

Quality Lab Associate I - Environmental Monitoring

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Marion

Salary:

68000.00 - 93500.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. degree in Microbiology, Biology, or related science
Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred
Strong communication and project management skills
Possess knowledge of core manufacturing and support systems
Computer literate/knowledge of Microsoft office applications (Word, Excel)
Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment
Proficient in the aseptic use and handling of media plates and swabs for EM sampling
Must be a dedicated individual who requires minimal direction
Attention to detail and strong organizational skills
Must have a basic understanding of laboratory instrumentation

Job Responsibility

Conduct microbiological analyses on raw materials, in-process and finished products
Use laboratory instrumentation and computer systems to collect and record data
Complete all testing, including special project / protocol testing in a timely following local procedures and cGMP regulations
Maintain data integrity and ensure compliance with regulatory agencies
Operate equipment such as SAS Air Sampler and Climet Particle Counter for the purpose of collecting air/particulate samples
Perform surface sample testing using plate and/or swab method
Collect water samples throughout the facility on a weekly/monthly basis
Perform weekly and monthly HEPA inspections to ensure integrity of HEPA filters in clean-rooms
Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean-rooms
Perform IMD (Instantaneous Microbial Detection) Testing

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

Quality Lab Associate I - Environmental Monitoring (7pm-7am)

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 Microbiology, Biology, or related science
Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred
Strong communication and project management skills
Possess knowledge of core manufacturing and support systems
Computer literate/knowledge of Microsoft office applications (Word, Excel)
Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment
Proficient in the aseptic use and handling of media plates and swabs for EM sampling
Must be a dedicated individual who requires minimal direction
Attention to detail and strong organizational skills
Must have a basic understanding of laboratory instrumentation

Job Responsibility

Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts
Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms
Conduct microbiological analyses on raw materials, in-process and finished products
Use laboratory instrumentation and computer systems to collect and record data
Complete all testing, including special project / protocol testing in a timely following local procedures and cGMP regulations
Maintain data integrity and ensure compliance with regulatory agencies
Operate equipment such as SAS Air Sampler and Climet Particle Counter for the purpose of collecting air/particulate samples
Perform surface sample testing using plate and/or swab method
Collect water samples throughout the facility on a weekly/monthly basis
Perform weekly and monthly HEPA inspections to ensure integrity of HEPA filters in clean-rooms

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

Select Country

Associate I, Quality Laboratory

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Associate I, Quality Laboratory

Associate I, Quality Laboratory

Associate I, Quality Laboratory

Sr. Associate I, Quality Control

Sr. Associate I, Quality Control

Sr. Associate I, Quality Control

R&D Quality Laboratory Oversight (Associate Director)

Quality Lab Associate I - Environmental Monitoring

Quality Lab Associate I - Environmental Monitoring (7pm-7am)

Our AI answers in your language