Pharmaceutical Product Stability Analyst

Missouri  ‐ Onsite
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Keywords

Description

Review, trend, and transcribe Biologics stability data in preparation for regulatory filings.
Duties:
  • Retrieve data from LIMS (Laboratory Information Management System) database or other data repository
  • Transcribe data into stability sections of regulatory filings, or perform 100% accuracy verification for previously transcribed data
  • Review sample results within LIMS to identify incomplete testing
  • Evaluate data
  • Identify and plot product degradation trends
  • Notify Stability Lead of any unusual findings or gaps in data trends
  • Assist Stability Leads with various tasks as necessary
  • Assist with sample handling duties as needed
  • Data transcription and verification and LIMS sample review will be majority of workload
SKILLS:

Skills Required:
  • Ability to work in a highly regulated environment and learn/comply with GMP expectations
  • Background in biochemistry, biology, chemistry, or related scientific discipline
  • Basic understanding of results from typical bio-analytical testing: ie HPLC, Electrophoresis, ELISA, Compendial assay, etc.
  • Ability to accurately transcribe data from Excel documents to MS Word
  • Ability to thrive in a fast-paced environment and adapt to changing priorities
  • Familiar with Microsoft Office Suite, and computer literate enough to quickly learn new systems
  Skills Desired:
  • Experience working in a GMP environment
  • Understanding of normal pharmaceutical development processes
  • Experience or understanding of ICH Q1A
Start date
n.a
From
Synectics
Published at
17.03.2015
Project ID:
868893
Contract type
Freelance
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