The Chemistry technician executes testing in the chemistry laboratory at the Xellia Cleveland site to include: TOC and Conductivity for WFI, identification by FTIR and FTNIR, in-process testing by instrumental and wet chemistry techniques, and to assist in qualification of laboratory instruments. The Chemistry technician is also responsible for assisting in root cause analysis for deviation investigations as needed and to continue to maintain a clean and 5S laboratory. It is critical that the candidate have an understanding of good documentation practices according to cGMP standards.
Ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards.
Maintain all training records in order to ensure compliance in cGMP facility.
Perform TOC, Conductivity and Appearance testing for Water For Injection (WFI).
With guidance from the QC Chemistry Lead or QC Manager, able to qualify laboratory equipment to include execution of IQ/OQ/PPQ protocols and reports.
Document all work performed according to applicable Current Good Documentation Practices.
Support activities associated with investigations related to CGLP analytical processes for Xellia Pharmaceutical LLC Products.
Coordinate and manage the progression of laboratory test data, SOP's, test procedures, method/equipment validation protocols and reports as defined by processes.
Obtain from QA the appropriate logbooks and ensure logbooks are reviewed, complete and reconciled according to procedure.
Responsible for handling of waste and transfer to central point as defined by procedures.
Perform laboratory cleaning routinely, including glassware washing and maintenance in preparation of laboratory inspections including regulatory inspections and to ensure good housekeeping is followed.
Understand and maintain 5S principles.
Communicate inventory needs for test materials and supplies.
Under the supervision of a Chemist performs routine tests.
Manage and escalate Quality issues to the QC Chemist Lead or QC Manager.
Work regularly under desirable conditions of the office setting but has occasional exposure to moderately disagreeable features of noise, heat or production conditions.
Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
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, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
Perform additional tasks in relation to quality issues as agreed with the QC Chemistry Lead.
Associate Degree in Science or related discipline (chemistry or chemical engineering preferred) or combination of education/experience
Thorough understanding of cGMP's and FDA requirements for laboratory operations
Proven ability to work with well with peers in a team environment
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.