Microbiologist II

Diasorin•Stillwater, MN

3d•$80,000 - $100,000

About The Position

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist." Why Join Diasorin? Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact! Job Scope Support the Operation teams as a subject matter expert, in performing troubleshooting and investigation into Bioburden and Environmental failures. Strong working knowledge of quality system regulations/requirements and ability to implement changes where necessary.

Requirements

BS/MS in Microbiology or a relevant field required
5+ Years of experience working as a Microbiologist in Biotech, Pharmaceutical, Medical Device or cGMP regulated industry. required
Experience with Bioburden/growth determination systems and aseptic methods; experience with gram negative and gram positive, anaerobic bacteria, environmental fungi identification and testing methodologies. required
Strong knowledge of quality system regulations/requirements (FDA, EU, ISO, USP).
Excellent written and verbal communication skills, excellent documentation and organizational skills.
Demonstrated critical thinking skills and attention to detail.
Ability to take ownership of assigned tasks and responsibility for the results.
Ability to perform multiple tasks.
Ability to work in a team environment and interact with various departments.
Ability to train others in the area functions needed for performance of job and review work for accuracy and alignment with procedures.
Intermediate proficiency in MS Word, PowerPoint and Excel skills and statistical programs (i.e. Minitab), Google Suites.
Work with biohazardous materials.
Frequently Safety Glasses, lab coat, surgical gloves are some but not all PPE requirements.
Frequently
Travel Requirements 10%

Responsibilities

Conduct routine analysis of products, stability samples, validation samples and Environmental samples through testing, data analysis/interpretation, method validation and continuous improvement projects.
Develop, review and revise standard operating procedures.
Train laboratory personnel on microbiological test methods.
Initiate, investigate and execute NCRs, deviations, change plans and out-of-spec results as necessary.
Consistently produce a high level of documentation accuracy and clarity according to cGMP documentation practices; author and review technical or quality methods, procedures, protocols and reports in accordance with GDP.
Monitor trending of Bioburden and Environmental test results.
Investigate and facilitate the solving of equipment/facility environmental and bioburden problems.
Perform vendor sourcing and selection of supplies.
Present technical information in formal settings.
Perform equipment qualifications as necessary.
Generate ideas leading to new or improved products and internal processes and help to implement where necessary.
Perform other special projects and duties at the discretion of immediate manager.