Quality Control Analyst II
Company Name:
Baxter
## Description
The Brooklyn Park facility is being prepared for development and commercial scale production activities related to the company's developmental antibody platform and biosimilars program.
This is a position within the quality control chemistry department. The position will support activities that may include general lab readiness projects, lab equipment qualification, assay transfer, assay qualification, and assay validation to prepare for GMP production. The analyst will also routinely perform analytical or bio-analytical chemistry tests to support in-process, drug substance, drug product, and stability samples.
Essential Duties and
Responsibilities:
Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from Baxter manufacturing facilities or Contract Manufacturing Organizations, etc.
Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS and Empower systems). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
Complete all testing, including special project / protocol testing in a timely and appropriate manner.
Initiate and obtain applicable approval for test requests
May maintain inventory/supplies necessary to conduct routine testing
Follow continuous improvement practices (QLP, 5S, LEAN, etc.)
Performs equipment maintenance and calibrations as required.
May serve as mentor to Quality Control Analyst (QCA) I positions. Provide training and work direction for QCA I positions as required.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
Writes exception documents.
Participate in functional efforts 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.
May perform other duties as assigned.
## Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Proficient in wet and instrumental methods of analyses.
Advanced laboratory skills and basic knowledge of statistical method.
Strong technical problem solving skills
Ability to handle multiple tasks concurrently, and in a timely fashion.
Must communicate effectively (verbal and written) with supervisors and peers.
Must demonstrate effectiveness in ability to train others
Knowledge of most laboratory equipment including but not limited to analytical equipment
Must be proficient in a variety of mathematical operations and calculations and be able to work with
both the metric and US standards of measurement.
Must be able to read and follow detailed written instructions and have good verbal/written communication
skills.
Knowledge of basic chemical and biological safety procedures.
Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint.
Education and/or
Experience:
Bachelors Degree in Chemistry, Biochemistry, Biotechnology or Biological Sciences
with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry,
r Biological Sciences, with 0-3 years experience. Appropriate additional certifications may be required pursuant to state or federal regulatory requirements
Job: Quality
Primary Location: United States-Minnesota-Brooklyn Park
Organization: BioScience Support
Schedule: Full-time
Job Posting: Apr 18, 2014, 11:36:07 AM
Unposting Date: Ongoing
Req ID: 66985BREstimated Salary: $20 to $28 per hour based on qualifications.
Baxter
## Description
The Brooklyn Park facility is being prepared for development and commercial scale production activities related to the company's developmental antibody platform and biosimilars program.
This is a position within the quality control chemistry department. The position will support activities that may include general lab readiness projects, lab equipment qualification, assay transfer, assay qualification, and assay validation to prepare for GMP production. The analyst will also routinely perform analytical or bio-analytical chemistry tests to support in-process, drug substance, drug product, and stability samples.
Essential Duties and
Responsibilities:
Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from Baxter manufacturing facilities or Contract Manufacturing Organizations, etc.
Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS and Empower systems). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
Complete all testing, including special project / protocol testing in a timely and appropriate manner.
Initiate and obtain applicable approval for test requests
May maintain inventory/supplies necessary to conduct routine testing
Follow continuous improvement practices (QLP, 5S, LEAN, etc.)
Performs equipment maintenance and calibrations as required.
May serve as mentor to Quality Control Analyst (QCA) I positions. Provide training and work direction for QCA I positions as required.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
Writes exception documents.
Participate in functional efforts 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.
May perform other duties as assigned.
## Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Proficient in wet and instrumental methods of analyses.
Advanced laboratory skills and basic knowledge of statistical method.
Strong technical problem solving skills
Ability to handle multiple tasks concurrently, and in a timely fashion.
Must communicate effectively (verbal and written) with supervisors and peers.
Must demonstrate effectiveness in ability to train others
Knowledge of most laboratory equipment including but not limited to analytical equipment
Must be proficient in a variety of mathematical operations and calculations and be able to work with
both the metric and US standards of measurement.
Must be able to read and follow detailed written instructions and have good verbal/written communication
skills.
Knowledge of basic chemical and biological safety procedures.
Good computer skills, knowledge of Microsoft Word, Excel and Powerpoint.
Education and/or
Experience:
Bachelors Degree in Chemistry, Biochemistry, Biotechnology or Biological Sciences
with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry,
r Biological Sciences, with 0-3 years experience. Appropriate additional certifications may be required pursuant to state or federal regulatory requirements
Job: Quality
Primary Location: United States-Minnesota-Brooklyn Park
Organization: BioScience Support
Schedule: Full-time
Job Posting: Apr 18, 2014, 11:36:07 AM
Unposting Date: Ongoing
Req ID: 66985BREstimated Salary: $20 to $28 per hour based on qualifications.
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