Proclinical is seeking a Senior QC Analyst to permanently join a dynamic team. This role focuses on supporting the startup of a new production facility dedicated to manufacturing Ac-225, a critical radiotherapeutic for cancer treatment. You will play a key role in ensuring the quality of Ac-225 through advanced analytical techniques such as gamma spectrometry and ICP-MS, while adhering to current Good Manufacturing Practices (cGMP). This is an exciting opportunity to contribute to cutting-edge innovation in a fast-paced, regulated environment.
Responsibilities:
1. Qualify equipment and develop methods for analyzing Ac-225 solutions using specialized techniques (e.g., ICP-MS, gamma spectrometry, endotoxin determination).
2. Analyze in-process control samples, starting materials, and Ac-225 batches using advanced analytical methods.
3. Ensure all qualified equipment and analytical methods comply with cGMP regulations.
4. Report data according to standard protocols.
5. Manage quality control of raw materials and incoming goods.
6. Perform recalibration and maintenance of laboratory equipment.
7. Write and maintain Standard Operating Procedures (SOPs).
8. Collaborate with subcontractor analytical laboratories as needed.
Key Skills and Requirements:
9. Master's degree in Analytical Chemistry or a related field.
10. Proven experience with ICP-MS.
11. Experience in radiochemical analysis.
12. Familiarity with GMP standards and regulatory environments.
13. Willingness to learn new analytical techniques and work with radioactive materials.
14. Proficiency in specialized techniques such as ICP-MS and gamma spectrometry.
15. Strong analytical skills with attention to detail.
16. Ability to work independently and collaboratively within a team.
17. Adaptability to a fast-paced and evolving environment.