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The opportunity
In this microbiology laboratory position, your main responsibilities will be scheduling and supporting microbiological laboratory testing, data review, analysis of endotoxin and bioburden samples, and evaluation of environmental monitoring (EM) activities (including preparation of EM trend reports) within a GxP-compliant QC microbiology laboratory to support pre-clinical studies, clinical development and commercial production for biological products manufactured in a GMP production facility.How you’ll spend your day
Position Summary:
•    Perform microbiological testing activities (e.g., bioburden, endotoxin, special studies and qualifications) within a GxP-compliant QC microbiology laboratory to support pre-clinical studies and clinical development for biological products manufactured in a GMP production facility.•    Possess background and experience with aseptic techniques and environmental monitoring (EM) programs, including EM collection techniques.•    Conduct and write investigations independently or with minimal assistance.•    Prior experience in a GMP microbiology laboratory, and experience working with microorganism cultures and identification systems (e.g., MALDI) is a plus.•    Use and apply scientific/technical standards, principles, theories, concepts and techniques of bio-pharmaceutical drug development and GxP requirements.•    Display sound scientific/technical judgment and ability to review work for overall adequacy and accuracy.•    Demonstrate knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) as applicable to the integral responsibilities of this position.•    Contribute actively to work on and resolve various scientific/technical problems of moderate scope and complexity.•    Work under general supervision. Follow established written procedures and processes.•    Support improving existing procedures and/or establishing new procedures.•    Contribute to completion of milestones associated with specific projects, both as an individual contributor and as part of the team.•    Frequent contact with project leaders and professional staff on goals, progress and resolution of issues. Infrequent inter-organizational and outside contacts on routine matters.