Be the backbone of innovation and join a leading pharmaceutical company to help keep life-changing science moving forward
Proclinical is seeking a QC Chemist to provide analytical chemistry services and support. You will focus on stability testing and ensure compliance with regulatory standards. This role requires effective collaboration with various departments and maintaining high-quality laboratory practices.
Responsibilities:
1. Conduct stability testing and provide analytical chemistry support.
2. Collaborate with Quality Assurance, Production, Engineering, and Planning teams.
3. Maintain and update chemical methods, specifications, and SOPs.
4. Train analysts in new methods and updates.
5. Trend results, record on Certificates of Analysis, and complete investigations promptly.
6. Communicate potential issues and suggest improvements to the QC Team Leader.
7. Ensure quality documentation and records are current.
8. Maintain compliance with Good Laboratory Practice (cGLP) requirements.
9. Define and follow relevant procedures accurately.
10. Validate chemical testing equipment as required.
11. Audit and review chemistry test results daily for compliance.
12. Check and audit laboratory notebooks and analytical reports.
13. Ensure adherence to current Good Manufacturing Practice (cGMP).
Key Skills and Requirements:
14. Experience in stability testing.
15. Strong analytical chemistry skills.
16. Ability to interact effectively with multiple departments.
17. Knowledge of pharmacopoeial and regulatory requirements.
18. Proficiency in training and mentoring analysts.
19. Familiarity with cGLP and cGMP standards.
20. Competence in equipment validation processes.