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Quality Scientist

Quality Scientist

SigmaSaint Louis, MO, US
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Quality Scientist (QC Microbiology)

The Quality Scientist (QC Microbiology) is responsible for microbiology related analysis specifically including but not limited to in-process, drug substance, raw material and water sample analysis. Job duties include :

  • Conduct and lead testing of raw materials and products using a variety of equipment and compendial methodology and non-compendial methods, including analytical and microbiological testing for quality compliance and release.
  • Perform technical review of assays and assist in method development, process improvements and resolves complex technical issues through analytical thinking and troubleshooting using established or advanced technologies.
  • Ensuring that suitable written records and work undertaken are kept in accordance with cGMP and company procedures.
  • Working within various internal departments to improve and execute processes used in an ICHQ7 environment.
  • Assisting with OOS / OOT investigations and root cause analysis investigations.
  • Interacting with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Maintaining and updating relevant Ops.

Minimum Qualifications :

  • Bachelor's Degree in Biology, Chemistry, or other Life Science discipline.
  • 5+ years of microbiology experience in a cGMP environment.
  • Preferred Qualifications :

  • API knowledge.
  • Knowledge of SOPs, cGMPs, GLP, GDP and quality control processes.
  • Knowledge and understanding of endotoxin (USP
  • and Bioburden (USP

    testing

  • Experience with ICH Q7, 21CFR210, USP and EP.
  • Experience writing technical documents and reports.
  • Knowledge of aseptic technique and practices.
  • Ability to perform minor troubleshooting on microbiological processes and associated laboratory equipment.
  • Experience with documentation control : writes, reviews, and approves operating procedures, reports, protocols, and other QC controlled documents.
  • Familiar with basic scientific / regulatory principles.
  • Excellent written and verbal communication skills.
  • Capacity to work independently.
  • Ability to simultaneously manage multiple tasks / priorities good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and the ability to learn and operate other specific application software.
  • Strong problem-solving and time management skills.
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    Scientist • Saint Louis, MO, US