Microbiologist II
Xellia

The Microbiologist II supports the testing in the Microbiology laboratory at the Xellia Cleveland site. In this role, the Microbiologist II 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 position will work 2nd shfit, Tuesday - Friday. 2pm - 12am

Key Responsibilities

• Document all work performed according to applicable Current Good Documentation Practices
• Document control, sample receipt, and check-in
• Microbiological testing to primarily include bioburden, endotoxin, identification of microorganisms, particulate analysis, growth promotion, and raw material and API analysis
• Data review, analysis, and interpretation
• Responsible for handling of waste and transfer to central point as defined by procedures
• Perform necessary laboratory and equipment maintenance and cleaning
• Maintain the laboratory supply through regular inventory management
• Communicate inventory needs for test materials and supplies
• Technical writing to include protocol and method development
• Perform additional tasks as needed
• Instrument and method qualification/validation
• Document review
• Clearly communicates complex issues to Management personnel.
• Support laboratory investigations and deviations
• Responsible for training laboratory personnel
• 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
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face,
• 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
• 1 to 3 years of experience in a cGMP laboratory (pharmaceutical/medical device) 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 several 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 a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.

Further information about Xellia can be found at: www.xellia.com
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