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Would you like to join an award winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Our Bedford, OH facility is seeking a Microbiologist to support the testing in the Microbiology laboratory at the Xellia Cleveland site. In this role, the Microbiologist II is responsible for will be responsible for all 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 is a 2nd shift position*
Key Responsibilities
- Microbiological testing to include; bioburden, endotoxin, identification of microorganisms, particulate analysis, raw material sampling, and API analysis
- Data review, analysis, and interpretation
- Instrument and method qualification/validation
- Document review
- Ensures that current procedures are followed in the execution of all tasks
- Clearly communicates complex issues to Management personnel.
- Document all work performed according to applicable Current Good Documentation Practices
- Support laboratory investigations and deviations
- Responsible for training laboratory personnel
- 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 to include protocol and method development
- 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. 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
- 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
Qualifications
- 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 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
Information og data
Denne ledige stilling har jobtypen "Biolog", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Biolog
- København
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