Data Reviewer Scientist - Rochester MI

Scientist, Data Reviewer Rochester MI

Kelly Science & Clinical has an opening for a long-term, contracted, fully-benefitted, Data Reviewer Scientist for one of our reputable clients in the Rochester MI area.

Salary range/work setup/hours: $90-95/yr and based on experience/100% onsite/M-F, 8AM 5PMEST; some flexibility with working hours applicable

Primary Responsibilities and Experience

• Validates analytical methods for Finished Product and Raw Material release and stability testing
  
• Evaluates, troubleshoots/improves existing analytical methods when necessary
  
• Prepares method validation protocols, reports, and analytical test methods
  
• Performs work to support project as assigned with little oversight
  
• Presents analytical data to project team for review and discussion
  
• Reviews and approves laboratory test data and documentation (e.g., notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary
  
• Reviews and evaluates drug substance suppliers technical documents to ensure internal test requirements are adequate
  
• Uses laboratory software for analyses
  
• Is alert to and detects abnormalities during performances of tests
  
• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
  
• Troubleshoots instrumentation and performs subsequent analyses Investigations
  
• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action
  
• Participates in root cause identification of complex laboratory investigations
  
• Writes, edits, and reviews SOPs and laboratory investigations
  
• Trains junior Scientists/Chemists on analytical techniques
  
• Continuously updates knowledge with respect to the latest technologies related to analytical science
  
• Maintains assigned training records current and in-compliance
  
• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies, and procedures Compliance
  
• Identifies need for SOPs and writes or revises, as appropriate
  
• Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting.
  
• Works in compliance with cGMP/cGLP regulations
  
• Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
  
• Takes active role in auditing laboratory logbooks/documentation to ensure compliance
  
• Follows internal processes related to controlled substances Safety
  
• Follows EH&S procedures to ensure a safe work environment
  
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS
  

Education/Background/Qualifications:

• Bachelor of Science Degree, Masters Degree, or PhD in chemistry, chemical engineering, or related field with 3-4 years relevant analytical experience as well as quality focused / data review background
  
• Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g., Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations, and custom reports
  
• Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
  
• Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
  
• Competency in Microsoft Office Suite Skills & Abilities
  
• Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information
  
• Ability to display and analyze data in a logical manner
  
• Strong verbal and written communication skills as well as good computer skills
  
• Strong attention to details and accurate record keeping
  
• Establish and maintain cooperative working relationships with others
  
• Solid organizational skills
  
• Ability to coach less senior staff and develop laboratory skills and ability
  
• Ability to take initiative, set priorities and follow through on assignments
  

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

9911417