Quality Analytical Scientist - Allegan MI

Kelly Science & Clinical has a long-term contract opportunity for a Quality Analytical Scientist in Allegan, MI! This position offers an enhanced benefits package as well. The need to fill this role is immediate

Day to Day Responsibilities:

• Perform physical and chemical testing on raw material, in-process, finished product and stability samples. This includes documentation and review.
  
• Develop, validate and transfer non-complex to complex analytical methods with minimal senior scientific staff assistance.
  
• Research, prepare and review technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards with minimal senior scientific staff assistance.
  
• Successfully investigate and resolve analytical problems, project issues and deviations with minimal senior scientific staff assistance. Accurately maintain all related documentation in compliance with SOPs.
  
• Prepare documents for regulatory filings (ANDA, NDA, ANDS).
  
• Design experiments and provide data to support responses for FDA minor deficiency letters with minimal senior scientific staff assistance.
  
• Other duties as assigned

Qualifications:

• Bachelors degree or higher, with general experience in a laboratory setting preferred.
  
• 5 years of analytical development experience.
  
• Familiarity with a variety of analytical techniques and instrumentation, including but not limited to UPLC, HPLC, GC, dissolution, UV-Vis and FTIR.
  
• Demonstrated mechanical aptitude with troubleshooting skills.
  
• Excellent communication skills are essential to work effectively in interdisciplinary teams and investigate and resolve technical problems.
  
• Experience with computer software programs such as Microsoft Word and Excel, and laboratory software program experience.
  
• Must be able to work within a Chemistry Lab, perform testing, and prepare samples with reasonable accommodation.

Pay will be based on title, education, and related Industry experience. If you, or someone you know, would like to be considered for this role, please apply online today to discuss the next steps!

For more information or to be considered, please contact me directly at ... or at ...

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