QC Microbiology Scientist

Location: College Station, TX
Department: Azzur Austin, LLC

Job Description

We at Azzur Group are looking for an experienced QC Microbiology Scientist to immediately join our Azzur Consulting: Austin team. The QC Microbiology Scientist is an FTE project based role. This position is responsible for conducting OOS investigations, trending site Environmental Monitoring and Critical Utility data and authoring quarterly and annual trend reports, completing data review or micro data, and acting as a QC Microbiology SME.

RESPONSIBILITIES:
  • Work with a team in QC Microbiology and the site investigator team to gather MODA information and to write deviations, alert/action level excursions, and OOS investigations
  • Trend site Environmental Monitoring (EM) and Critical Utility (CU) data and author quarterly and annual trend reports
  • Execute change controls to update QC Microbiology procedures based on annual analysis of alert levels and root cause of analysis of investigations
  • Work with analysts to ensure EM testing is conducted on schedule
  • Act as a QC Microbiology SME during internal/external audits, risk assessments, and cross functional investigations
  • Ensure continued professional development of staff through training and functional interactions with various operating groups
  • Provide investigation support and product impact assessment following microbiologic excursions
  • Ensure that all relevant Trending for environmental monitoring, bioburden and critical utilities monitoring is accurate, timely and actionable
  • Microbiological Assessment that supports lot release
  • Provide leadership in conducting risk assessments pertaining to contamination control
  • Remain knowledgeable of external regulations and trends related to contamination control
  • Maintain compliance with GMP and GLP guidelines
  • Assist and support all quality control activities and deliverables as assigned
  • Demonstrate a "right-first time" attitude and attention to detail
  • Perform other duties as assigned

REQUIREMENTS:
  • Bachelor’s Degree in biological sciences required, with a minimum of 5 years of industry experience in microbiology
  • Proven ability to manage timelines and meet internal/external deadlines
  • Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals
  • The use of MODA and Microsoft Office programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. 


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