- Conduct critical chemical, and physical analyses on finished product stability samples. May also support testing of raw materials, initial, in-process, and final product samples from manufacturing facilities or department projects. Work under minimum supervision.
- Perform review of test data, which includes overall documentation practices.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data (LCMS system).
- Perform advanced 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.
- Collaborate with other functions/departments to solve problems, increase efficiency, improve quality and provide product support.
- Maintain laboratory safety requirements, perform equipment maintenance/calibration, and troubleshoot basic instrument problems
- Bachelor's degree in relevant scientific discipline (e.g. chemistry, pharmaceutical sciences) with analytical chemistry laboratory coursework and at least one (1) to two (2) years of experience OR advanced degree in Chemistry
- Analytical chemistry instrumentation experience (e.g. HPLC, UPLC, UHPLC, Mass Spectrometry)
- Pharmaceutical GMP laboratory experience is desired
- Residue analysis experience by LC-MS/MS is desired
- Must have good oral and written communication skills, strong analytical skills and be detail oriented.
- Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis
- Must demonstrate effectiveness in 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 recommendation to resolve technical challenges
- Must be able to hand write and use computers for the majority of the work day
- Must be able to transfer materials, mix solutions/product(s), open products, and perform laboratory testing
- May require standing for extended periods
- Must be able to lift up to 10 pounds routinely
- This work is subject to hazards including exposure to chemicals, drug products.
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Scientific Research Associate II - Round Lake, United States - Randstad Life Sciences US
Description
Immediate opportunity for a Scientific Research Associate II with experience running LCMS or related instrumentation (HPLC/UPLC). This position is responsible for analytical testing, validation/verification, and/or transfer of test method supporting Pharmaceuticals parenteral products. Work will primarily support new product development and sustaining product initiatives and will conduct research and design experiments with minimal assistance.
Schedule/Shift: 1st shift, Mon.-Fri.
Position Type: Contract positions for 8 mos. (through 12/31/24) with potential to extend.
Essential Duties and Responsibilities:
Qualifications:
Physical Requirements:
