Temp – QC Microbiology Scientist Full-time

Temp QC Micro Scientist

Within this role you will perform testing method development, optimization and validation for the QC Microbiology group. Provide technical support and guidance for release testing, in-process testing, and microbiological investigations. Provide technical expertise in regards to Environmental Monitoring.

As a Temp QC Micro Scientist a typical day might include, but is not limited to, the following:

• Validating methods and equipment related to sterility, bioburden, endotoxin testing, and microbial identifications.
• Writing technical documentation, including position papers, validation reports, and microbiological investigations.
• Culturing organisms, conducting research, and characterizing them for use in investigations and cleaning development.
• Reviewing new test procedures and assays for accuracy and compliance.
• Evaluating and acquiring new methodologies, techniques, and equipment as needed.
• Overseeing contract laboratory testing to ensure quality and compliance.
• Setting product specifications and alert/action levels for microbiological standards.
• Leading technical troubleshooting and problem investigations.
• Reviewing assay, process, and equipment validation reports, as well as other technical documents for correctness and regulatory compliance.
• Coaching junior team members on good microbiology lab practices and modern aseptic techniques.
• Leading audits of vendors, external laboratories, business partners, and contracted manufacturers as needed.
• Supporting and participating in regulatory inspections to ensure compliance.
• Possessing a strong background in pharmaceutical microbiology, GMP working experience in QC labs, and aseptic techniques.
• Demonstrating investigational skills and working knowledge of microbiology assay development and validation.
• Requiring advanced knowledge of aseptic manufacturing operations.

This Role Might Be For You If:

• You have a proven record to work independently or as part of a team
• You possess strong trouble-shooting and problem solving skills
• You have strong attention to detail & excellent written and oral skills

To be considered for this opportunity you should have a BS/BA or equivalent experience in Microbiology or related field and 2+ years of validated experience, or equivalent combination of education and experience.