Analyst, Global Stability
Job Description Summary
Experienced Analytical/Quality Control Analyst with 3–5 years of hands-on experience in an FDA-regulated pharmaceutical environment. Proficient in performing analytical testing of drug products and raw materials using techniques such as HPLC, GC, UV, and dissolution. Skilled in handling stability samples, method execution, data integrity compliance, and troubleshooting laboratory instruments. Strong understanding of cGMP, GLP, and FDA regulatory requirements, with a proven ability to ensure accurate documentation and compliance during audits and inspections.Job Description
- Perform routine and stability sample analysis as per approved specifications and test methods
- Operate and maintain analytical instruments (HPLC, GC, UV, Dissolution Apparatus, etc.)
- Review and document analytical data in compliance with cGMP and data integrity principles
- Investigate OOS/OOT results and support deviation and CAPA activities
- Ensure compliance with FDA, cGMP, and GLP requirements
- Prepare and review analytical reports, protocols, and SOPs
- Participate in method transfer, verification, and validation activities
- Support regulatory and internal audits
Key Skills:
- Strong knowledge of FDA regulations, cGMP, and data integrity
- Analytical troubleshooting and problem-solving skills
- Documentation and compliance expertise
- Team collaboration and communication