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Summary:
The position is responsible for testing of pharmaceutical products (commercial and R&D). The position will be in the Round Lake, IL Stability Laboratories within Global Product Quality serving multiple global businesses and testing sites.
A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.
Essential Duties and Responsibilities:
- Conduct critical chemical, physical, and biological analyses on finished product stability samples. May also support testing of 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 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 may 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.
Qualifications:
- Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis
- 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:
- Bachelors degree in Chemistry or biological science with analytical chemistry laboratory coursework and at least 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences.
- Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, 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.
Work Environment or physical requirements:
- Possess excellent quantitative analytical chemistry techniques.
- Normal visual acuity and ability to distinguish color are necessary.
- Must be able to lift and carry on average up to 15 pounds, stand for prolonged periods, and perform repetitive processes using both arms and hands.
- When working with pharmaceutical drugs, must enter health surveillance program and meet occupational health clearance to perform essential duties of the job.
- Ability to work in team oriented, dynamic fast-paced environment with competing priorities and due dates.
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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