Microbiologist
Xellia

Job Info

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The Microbiologist supports the testing in the Microbiology laboratory at the Xellia Cleveland site. In this role, the Microbiologist I is responsible for aspects of the Microbiology laboratory operations, such as sample receipt, sample testing, data generation, data analysis and summarization and other QC lab supporting activities. Uses good documentation practices in the collection of data/records. Authors and executes qualification documents, SOPs, protocols, and investigations. Recommends corrective actions or process improvements that will eliminate the potential for laboratory deviations.

This is a second shift position - 4 10's (Wed - Sat) 11am - 9pm

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Key Responsibilities

• Microbiological testing to include; bioburden, endotoxin, identification of microorganisms, particulate analysis, and raw material sampling
• Data analysis and interpretation
• Document all work performed according to applicable Current Good Documentation Practices
• Perform necessary equipment maintenance and cleaning
• Maintain the laboratory supply through regular inventory management
• Communicate inventory needs for test materials and supplies
• Document control, sample receipt, and check-in
• Technical writing
• Responsible for handling of waste and transfer to central point as defined by procedures
• Perform laboratory cleaning
• Participation in continuous improvement initiatives to improve work practices in quality department
• Help ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards
• Perform additional tasks as needed
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. . Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.
• Protective apparel, such as lab coat, head, face, hand, and arm coverings, shall be worn as necessary to promote safety and to protect drug products from contamination

Requirements

• Bachelor's degree in a Scientific discipline (Microbiology, Biology, Biotechnology, Biochemistry, etc.) or equivalent
• 0 to 2 years of experience in a laboratory environment
• Basic computer skills: Microsoft Office programs such as Excel, Word, Power Point
• Experience working in a laboratory environment.
• Critical thinking and problem solving ability desired.

Physical Requirements of the Role

Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is often sitting and typing. Frequently talking, standing, walking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 50 lbs. Bending over, and repetitive use of legs are done occasionally. Work regularly under desirable conditions of the office and laboratory setting but has occasional exposure to moderately disagreeable features of noise, heat or production conditions.

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here

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