Sr QC Chemist – FILLED
Sr QC Chemist from The Wellington Group @twgrecruiters
The Wellington Group has been engaged to find an experienced Sr QC Chemist to serve as the Scientist and management support for a leading medical technologies company. Put your QC Chemistry experience to work in a new job today!
The Sr QC Chemist is responsible for leadership and management support of various functions such as laboratory testing and data analysis, test method development, validation and tech transfer, stability testing and/or study coordination, and project management. Must have hands on FDA regulations experience such as GMPs, ISO 13485 other relevant guidance and regulations.
Sr QC Chemist requirements:
- Perform analytical and chemical techniques such as HPLC, UV/Vis and wet chemistry analyses
- Assist with method development, validation, and transfer
- Serves as technical lead with department and plant management, including presentations and meetings
- Provides leadership and/or support for assigned group and plant related projects
- Performs peer-review of laboratory work
- Maintain GMP/GLP laboratory notebooks and documentation relevant to the group
- Assist in managing the stability program
- Perform OOS Investigations, Non-conformances and CAPAs
- Review reports for In-process and Finished Goods for Quality Control Testing
The qualified Sr QC Chemist candidate will have:
- BS Degree in Chemistry, MS Degree is preferred
- 7+ years of experience in a cGMP laboratory
- Supervisory, management and/or leadership experience is ideal
- Must have method development, validation and transfer experience in the pharmaceutical or medical device industry
- Excellent oral and written communication skills with the ability to present data and issue resolutions to the staff and senior management
Industry: Chemistry, QC, CAPA, OOS, Method Development, Method Validation, Tech Transfer, HPLC, UV/Vis, GMP, ISO 13485,