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We are seeking a highly skilled and motivated Microbiologist to join our team in Madison, WI. As a Microbiologist, you will play a key role in ensuring the quality, safety, and integrity of our products by performing microbiological testing and analysis on raw materials, in-process samples, and finished products. This position will provide you with the opportunity to work in a state-of-the-art laboratory environment, supporting various departments and contributing to the company's mission to deliver high-quality products.

The ideal candidate will have experience in microbiological testing, quality control, and aseptic techniques, as well as a strong understanding of GMP, GLP, and regulatory compliance.

Key Responsibilities

Microbiological Testing:

Conduct microbiological testing on raw materials, finished products, in-process samples, and environmental samples to identify microbial contamination.Perform tests such as microbial limit testing, E. Coli Testing, Salmonella testing, sterility testing, and microbial identification using various techniques (e.g., PCR, ELISA, Gram staining, microscopy).Prepare microbiological media, reagents, and solutions for testing and ensure proper sterilization and quality of materials.

Aseptic Technique:

Perform aseptic techniques for microbiological analysis and environmental monitoring, ensuring that all testing is conducted in compliance with regulatory standards.Maintain sterile conditions in the laboratory environment to prevent cross-contamination of samples.

Quality Control and Compliance:

Follow and ensure adherence to Good Laboratory Practices (GLP).Maintain accurate records of testing, results, and investigations in accordance with company SOPs and regulatory guidelines (e.g., FDA, ISO).Assist in investigations of out-of-specification (OOS) results, identifying root causes, and implementing corrective actions as needed.

Laboratory Maintenance:

Maintain and troubleshoot microbiological laboratory equipment, including incubators, autoclaves, laminar flow hoods, and analytical instruments.Ensure that laboratory environments are regularly cleaned and sanitized to meet regulatory standards.Perform routine calibration and validation of microbiological instruments.

Data Analysis and Reporting:

Analyze microbiological test results and generate reports for internal and external stakeholders.Interpret data and provide recommendations based on findings, contributing to continuous improvement in quality control processes.Document test results, trends, and deviations, and communicate findings to supervisors, quality assurance, and other departments as needed.

Training and Mentorship:

Provide training and guidance to junior laboratory staff and interns on microbiological techniques, equipment use, and safety procedures.Stay current with microbiological techniques and regulatory guidelines through ongoing education and training.

Regulatory Audits and Inspections:

Support internal and external audits, including preparation of documentation and responding to audit findings.Assist in the preparation of documents for regulatory submissions, including batch records, certificates of analysis (COA), and stability testing reports.QualificationsEducation:A Bachelor's degree in Microbiology, Biology, Biotechnology, or a related field is required.Experience:1+ years of experience working as a microbiologist/microbiology technician in a laboratory environment, preferably within the pharmaceutical, biotech, or food industries.Experience with microbial testing, environmental monitoring, and sterility testing.Previous exposure to GMP, GLP, and regulatory compliance in laboratory settings.Skills:Microbiological Testing: Proficient in performing microbiological assays such as microbial limit tests, Transfers/Streaks, PCR, and ELISA.Laboratory Equipment: Experience with microbiological laboratory equipment, such as Autoclaves, laminar flow hoods, and PCR machines.Data Analysis: Strong data analysis and interpretation skills, with proficiency in laboratory software, databases, and MS Office (Excel, Word).Problem-Solving: Ability to troubleshoot and resolve technical and operational issues in a laboratory setting.Attention to Detail: High level of accuracy in conducting experiments, recording data, and interpreting results.Communication Skills: Strong written and verbal communication skills for preparing reports, documenting results, and presenting findings.Team Collaboration: Ability to work effectively as part of a team and collaborate with other departments.Physical Requirements:Ability to stand for extended periods and perform tasks that require manual dexterity.Ability to lift laboratory materials up to 25 pounds.Ability to work in a laboratory environment, which may include exposure to chemicals, biological agents, and laboratory reagents.Work Environment and Conditions:Location: This position is based in Madison, WI at our laboratory facility.Work Schedule: Full-time position, with standard business hours. Occasional overtime may be required based on testing and project needs.Laboratory Setting: Work will be performed in a laboratory environment requiring adherence to safety protocols, the proper use of personal protective equipment (PPE), and compliance with regulatory requirements.Why Join Us?Career Growth: Opportunity for career advancement in a growing and dynamic laboratory environment.Training and Development: Ongoing professional development and training opportunities to stay up-to-date with the latest microbiological techniques and industry standards.Collaborative Environment: Work in a collaborative team-oriented environment where your contributions are valued.Competitive Compensation: We offer a competitive salary and benefits package, including health insurance, retirement savings, paid time off, and more.How to Apply

If you are passionate about microbiology and are looking for a challenging and rewarding opportunity, we encourage you to apply. Please submit your resume and a cover letter outlining your relevant experience and interest in the position.

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