#x 9; The position will involve routine testing of developmental samples for stability. Perform chemical and physical testing on the finished products, in-process samples and stability samples. Validate and transfer analytical methods. Prepare analytical method validation protocols, method validation reports, test methods, conduct laboratory investigations and deviations. Prepare and maintain accurate and complete technical documentations, such as laboratory notebooks. Perform chemical and physi... more details
Kelly Outsourcing Consulting Group has an opening for a Research Associate for a long-term engagement at one of our Global medical device clients in Fort Washington PA
The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, 401K, and annual performance reviews. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Job Description:
The position will involve routine testing of developmental samples for stability.
Perform chemical and physical testing on the finished products, in-process samples and stability samples.
Validate and transfer analytical methods.
Prepare analytical method validation protocols, method validation reports, test methods, conduct laboratory investigations and deviations.
Prepare and maintain accurate and complete technical documentations, such as laboratory notebooks.
Perform chemical and physical testing on the finished products, in-process samples and stability samples. Participate in analytical method development and present the results to the Method Development Committee.
Comply with cGMP requirements.
Become familiar with SOPs, applicable Quality Standards, Work Instruction, functional documentation and operational guidance.
Attend required safety training and maintain a safe work environment.
Scientist will be responsible of ensuring accuracy and successful completion of finished product method remediation activities.
Qualifiations:
Education: BS or MS, in analytical chemistry or a related field.
Scientist: BS in analytical chemistry with a minimum of 1-3 years of experience, or MS with 1-2 years of experience in analytical chemistry. .
Job Knowledge/Skillsets: Must have background and hands-on experience in UPLC, HPLC, GC, FT-IR, UV/VIS, wet chemistry techniques common to the pharmaceutical industry. Strong oral and written communication skills are required.
Experience with Documentum based document storage systems is highly preferred. Knowledge and experience with regulatory requirements including ICH, FDA, and compendia e.g. USP, JP, EP, etc. is preferred.
Good working knowledge of computer systems, including chromatographic data acquisition system e.g. Empower , LIMS, MS Word, and MS Excel are required.
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