Quality Lab Associate IIReq # JR - 026789 Location Round Lake, Illinois, United States Job Category Quality Control Date posted 09/01/2020
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The position may be responsible for analytical testing, validation/verification, and/or transfer of test methods supporting parenteral products. The position will be in the Round Lake, IL Stability Laboratories within Product Quality serving multiple global businesses.
This role is essential for supporting the global commercial product teams and/or product development teams. The position may interface with multiple functions (e.g. formulation and process development, manufacturing, and CRO/client partners).
The individual in this position must: 1) Effectively contribute solid technical knowledge to a variety of projects within the relevant discipline with minimal assistance. 2) Display basic technical understanding of related disciplines. 3) Conduct routine/non-routine experiments with minimal assistance.
Essential Duties and Responsibilities
- Conduct critical chemical, physical, and biological analyses on finished product stability samples. May also support testing of raw materials, initial, in-process and final product samples from the manufacturing facility, as required. Work under minimum supervision.
- Perform review of test data, which includes overall documentation practices. Perform review functions in LIMS or other computerized systems.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data. May be required to be a system owner and conduct validations.
- Perform advanced biological and chemical assays requiring precise analytical skills and understanding of chemistry principles.
- Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.
- Investigate deviations and write exception documents.
- Participate in cross functional teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality and provide new product support.
- Maintain laboratory safety requirements and perform laboratory audits as required. Audit SOPs and update, as required.
- Perform equipment maintenance and calibrations as required. Troubleshoot and resolve instrument problems.
- Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis including chromatography
- Proficient in particle analysis using particle measuring systems is preferred
- Must demonstrate effectiveness in ability to train others, leadership, organization, teamwork/interpersonal skills, results orientation, and task completion.
- Must be able to handle multiple tasks concurrently and in a timely fashion.
- Possess writing and computer skills.
- Must communicate effectively with managers, peers, and subordinates.
- Interpret available information and make recommendations to resolve technical challenges.
Education and/or Experience
- Bachelor’s degree in Chemistry or biological science with analytical chemistry laboratory coursework and at least 2-5 years’ experience, or Master’s Degree in Chemistry, or Biological Sciences.
- Analytical chemistry instrumentation experience. (e.g. HPLC, UPLC, UHPLC, PMS, GC, pH, KF, TOC, AA, GFAA, titrations, etc.)
- Pharmaceutical GMP/QC laboratory experience.
- Stability study execution experience is desired.
- Validation / Method Transfers experience is desired.
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.
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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.