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Summary:
The Quality Lab Associate II will be located at the Drug Delivery Chemistry Laboratories, Round Lake, IL. The Position encompasses the biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.
This is a third shift position but will be required to work on 1st and 2nd shifts/weekends to support training of analysts and to support projects and/or production, as required.
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.
Responsibilities include, but are not limited to, the following:
- Conduct critical biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility. Work under minimum supervision.
- Serve as a Mentor to Quality Laboratory Associate (QLA) positions. Provide training and work direction for QLA I positions as required.
- Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data.
- Perform advanced biological and chemical 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.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Investigate deviations and write exception documents.
- 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.
- Other projects as assigned.
Qualifications:
- Proficient in wet and instrumental methods of analyses. Strong HPLC background desired.
- Advanced laboratory skills, basic knowledge of statistical method.
- Strong technical problem solving skills.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Computer literate.
- Must be able to communicate effectively with supervisors and peers.
- Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.
- Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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