QC Microbiology Scientist Full-time

QC Tech Resources Micro Scientist

Within this role you will perform testing method development, optimization and validation for the QC-Tech Resources Microbiology group. You will provide technical support and guidance for release testing, in-process testing, and microbiological investigations. 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.
• 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.