Senior QC Specialist
The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides
In order to continue our organic growth, we are constantly looking for talent.
The Senior Quality Control (QC) Technicianwill be responsible for QC data reviews for API release and stability and assist the API and stability management with resolving release and stability related issues. This person will be responsible for writing deviations and assist with OOS and CAPA investigations, method remediation and troubleshooting. This person will perform release and stability testing, follow FDA/cGMP compliance regulations and meet customer commitments.
- Review API release and stability data and assist API and stability management with on time delivery of stability reports
- Perform release and stability testing
- Responsible for performing deviation investigations for QC API group and assist management with CAPA investigations
- Assists team members regarding instrument issues, helps with method remediation and OOS investigations
- Comply with SOP’s, STM’s and cGMP guidelines in all aspects of the work performed
- Assist in the training and evaluation of new hires to the required standards of performance
- Master’s Degree in Analytical Chemistry, Organic Chemistry or equivalent and a minimum of 4 years of experience in a cGMP QC Laboratory
- Bachelor’s Degree in Analytical Chemistry, Organic Chemistry or equivalent and a minimum of 6 years of experience in a cGMP QC Laboratory
- Fulfil all requirements of a QC Scientist III
- Extensive knowledge of instrumentation, peptide chemistry and analytical chemistry
- Excellent technical writing skills and experience with writing investigation reports
- Great attention to detail and excellent skills as a data reviewer
- Answers team member questions regarding instrument issues, helps with method remediation and OOS investigations
- Flexibility of working hours based on business needs, may include some nights and occasional weekends
- Familiar with equipment and utilities including but not limited to QC Laboratory
- Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area.
- Excellent written and oral communication skills
- Basic computer knowledge, including Chromeleon, LIMS, Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Communicate effectively and ability to function well in a team environment