Candidate Opportunities

Sr Chemical Analyst - 2018-031

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Location
Cook County, IL
Job Type
Direct Hire
Date
Nov 12, 2018
Job ID
2626231
A leader in pharma and biotech manufacturing, this client offers autonomy and is expanding. Known for long term employment with exceptional work/life balance and benefits, this opportunity offers great growth potential for the right candidate.
 
The ideal person will possess 5 years experience with some R&D and GMP experience. HPLC testing/analysis a great plus. Must be comfortable with a mixture of lab, documentation and customer
projects. 
 
Job Description

Responsibilities:
Conducts chemistry testing and equipment qualification in a timely and effective manner in accordance with standard operating procedures, regulations and cGMPs. Functions as the SME and represents the Chemistry Laboratory in customer projects. Organizes and assigns project work to Chemical Analyst(s). Provides leadership and mentoring to Chemical Analyst(s) 
 
Tasks:
  • Collaborates with management to assure continuous improvement of the GMP systems in the analytical chemistry laboratory
  • Lead role representing the Chemistry Department on customer projects
  • Conducts assessment, qualification, and introduction of new analytical methods and procedures
  • Technical expert for troubleshooting of test method execution and equipment issues
  • Responsible for training of colleagues in the Chemistry Laboratory
  • Responsible for completion and evaluation of Laboratory Investigations
  • Responsible for review of documentation and release of incoming materials such as API, excipients and processing auxiliaries.
  • Responsible for the setup of new incoming materials
  • Assures project milestones for the Chemistry Laboratory are being met in a timely manner (incoming material setup, laboratory qualifications, test plans, etc.)
  • Establishes, reviews, and approves documentation (stability protocols and reports, SOPs, laboratory qualification protocols and reports, etc.) 
  • Conducts, documents, and assesses analytical testing of raw materials, utilities and in-process, release, and stability testing of finished products in accordance with standard operating procedures and cGMPs/GLPs
  • Collects samples of raw materials and utilities
  • Responsible for maintaining the Chemistry Laboratory in a GMP state
  • Responsible for collaborating with vendors for the external qualification and maintenance of the chemical analysis instrumentation.  In addition, conducts internal qualification and maintenance of the chemical analysis instrumentation  
  • Responsible for review and verification of analytical testing 
  • Ensures that all tasks are conducted in compliance with all safety, environmental protection and cGMP regulations
 
Minimum requirements:
  • Bachelor’s or Master’s degree in a scientific subject 
  • Good knowledge of Quality Management systems
  • 5 yrs work experience in a GMP Chemical Analysis laboratory in the pharmaceutical industry
  • MS Office