CAREERS AT EXTHERA MEDICAl
Reporting to the director of Manufacturing, the QC Scientist schedules and performs routine activities in the analytical lab. The QC Scientist will play a role in supporting ExThera Medical R&D and Manufacturing. Ensure that all raw materials are tested and released for use in manufacturing. Ensure that all testing equipment is maintained and ready for use. He/she will be responsible, as needed, in analytical method development and implementation. Also performs various data reporting tasks, procedure writing and revising, as well as routine analytical testing and characterization responsibilities.
Duties & Responsibilities
- Responsible for testing and release of the products.
- Responsible for sending the samples to outside labs for testing.
- Responsible for the testing and release of the raw materials as per ExThera Medical Quality System to support manufacturing.
- Perform a variety of characterization tests to support Manufacturing and R&D such as HPLC, Particle Size Analyzer, Porosity Testing, FTIR, UV Spectrophotometry, and Moisture Analyzer.
- Responsible for interpreting data and meet strict guidelines on documentation when recording data
- Responsible for maintaining the inventory of supplies in the Analytical Lab.
- Perform technical writing of reports and procedures (including revisions)
- Responsible in developing techniques for the analysis of newly developed products.
- Responsible for ensuring that all testing equipment is routinely calibrated and functioning properly.
- Responsible for maintaining good housekeeping.
- Responsible for revising the SOPs when needed
- Responsible for handling and proper disposal of Hazardous Waste and Non-Hazardous wastes in accordance with safety protocols
- Must be able to work collaboratively in cross-functional teams
- Handle basic repair and maintenance of test equipment as well as more complex repairs on instruments of expertise
- Must be able to accurately follow the procedures and data recording that is required in the Analytical Lab SOP.
- Provides ongoing support for production scale-up and development work when needed.
- Provide training to other QC personnel personnel
- Comply with all ExThera Medical safety requirements, including posted placards, SOP and the Safety Manual.
- Adhere to ExThera Medical Quality System procedures and ISO 13485 Standard.
- Assist in repair and preventive maintenance for analytical Lab Equipment and facility.
- Assist other personnel in daily Manufacturing or R&D duties when needed.
- Assist in collecting data for the KPIs
- Assist in creating, executing and documenting Analytical Method validations when necessary.
- Assist in technical troubleshooting.
- Perform other duties assigned to meet business needs
BS Degree in Chemistry, Polymer Chemistry, Material Science or related scientific discipline that would support analytical lab activities. Minimum of 2-4 years experience in analytical chemistry that included on hands-on routine, testing, method development and validation.
Skills & Work Requirements
- Strong organizational skills.
- Strong attention to detail and accuracy.
- Critical thinking and problem-solving skills.
- Ability to provide innovative solutions to complex problems.
- High level of knowledge and experience with various analytical instruments valued especially those related to polymer characterization, HPLC and FTIR analyses.
- Knowledge related to regulatory requirements for GMP operations.
- Experience using standard MS Office software, particularly Word, Excel and PowerPoint
- Excellent communication skills.
- Must be easily adaptable to changing priorities and deadlines.
- Self-starter and a team player that will thrive in an entrepreneurial environment