Quality Lab Associate III - (1st Shift)
Company Name:
Baxter
## Description
Summary :
The Quality Lab Associate III performs advanced laboratory testing (biological, endotoxin, chromatography, etc.) that requires a variety of chemical, biological, or physical analyses on products/systems in support of the company's quality program. This role works as part of the quality control function, performing laboratory testing andtrains and leads others within the laboratory. This position reports to a Quality Control Chemistry Supervisor.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :
Performs advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles
Operates applicable laboratory equipment (HPLC, UV, Karl Fischer, pH meter, density meter, etc.)
A thorough knowledge of the US and EU pharmacopeias and a working knowledge of JP pharmacopeia.
Performs raw material testing.
Maintains data integrity and ensure compliance with company standard operating procedures (SOPs) and worldwide regulatory agency requirements
Initiates and writes Laboratory Investigation Reports
Performs general laboratory/personal area clean-up
Participates in lean manufacturing practices, which increase efficiency, solve problems, generate cost savings and improve quality
Serves as a mentor to other Quality Lab Associates
Provides training for Quality Lab Associate I and II positions
Performs review of test data, which includes overall documentation practices
Performs internal laboratory checklist and audits as required
Uses sophisticated laboratory instrumentation and computer systems to collect and record data
Works on special projects / protocol testing that involves new methods and instrumentation including validations, studies and development work
Laboratory software system ownership
Perform research and development studies
Performs equipment release testing in support of the Production Support group
## Qualifications
Job Requirements (Education, Experience and Qualifications ):
Bachelor's degree required, preferably in a physical science related field with a minimum of 5 years pharmaceutical laboratory experience, or a Masters degree in a physical science related field with a minimum of 1 year experience.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Knowledge of instrument/software/documentation repair and calibration systems required.
Knowledge and navigation skills of QC documentation required
Physical / Safety Requirements:
Must be able to wear personal protective equipment.
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position may require sitting or standing for long periods of time.
This position requires handling of laboratory chemicals
Must be able to qualify for 20/40 corrected vision.
Job: Quality
Primary Location: United States-Indiana-Bloomington
Organization: Baxter
Schedule: Full-time
Job Posting: May 9, 2014, 10:41:09 AM
Unposting Date: Ongoing
Req ID: 140001GSEstimated Salary: $20 to $28 per hour based on qualifications.
Baxter
## Description
Summary :
The Quality Lab Associate III performs advanced laboratory testing (biological, endotoxin, chromatography, etc.) that requires a variety of chemical, biological, or physical analyses on products/systems in support of the company's quality program. This role works as part of the quality control function, performing laboratory testing andtrains and leads others within the laboratory. This position reports to a Quality Control Chemistry Supervisor.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :
Performs advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles
Operates applicable laboratory equipment (HPLC, UV, Karl Fischer, pH meter, density meter, etc.)
A thorough knowledge of the US and EU pharmacopeias and a working knowledge of JP pharmacopeia.
Performs raw material testing.
Maintains data integrity and ensure compliance with company standard operating procedures (SOPs) and worldwide regulatory agency requirements
Initiates and writes Laboratory Investigation Reports
Performs general laboratory/personal area clean-up
Participates in lean manufacturing practices, which increase efficiency, solve problems, generate cost savings and improve quality
Serves as a mentor to other Quality Lab Associates
Provides training for Quality Lab Associate I and II positions
Performs review of test data, which includes overall documentation practices
Performs internal laboratory checklist and audits as required
Uses sophisticated laboratory instrumentation and computer systems to collect and record data
Works on special projects / protocol testing that involves new methods and instrumentation including validations, studies and development work
Laboratory software system ownership
Perform research and development studies
Performs equipment release testing in support of the Production Support group
## Qualifications
Job Requirements (Education, Experience and Qualifications ):
Bachelor's degree required, preferably in a physical science related field with a minimum of 5 years pharmaceutical laboratory experience, or a Masters degree in a physical science related field with a minimum of 1 year experience.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Knowledge of instrument/software/documentation repair and calibration systems required.
Knowledge and navigation skills of QC documentation required
Physical / Safety Requirements:
Must be able to wear personal protective equipment.
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position may require sitting or standing for long periods of time.
This position requires handling of laboratory chemicals
Must be able to qualify for 20/40 corrected vision.
Job: Quality
Primary Location: United States-Indiana-Bloomington
Organization: Baxter
Schedule: Full-time
Job Posting: May 9, 2014, 10:41:09 AM
Unposting Date: Ongoing
Req ID: 140001GSEstimated Salary: $20 to $28 per hour based on qualifications.
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