Quality Control – Manager

Quality Control – Manager in Boca Raton, Florida,Job Summary

We are seeking an experienced Quality Control Senior Executive / Manager to oversee analytical QC operations for sterile injectable products. The role requires strong hands‑on expertise in analytical techniques, regulatory compliance, and investigation handling within a GMP-regulated injectable manufacturing environment.

• Perform and oversee analysis of Raw Materials, In-Process Samples, and Finished Products
  .
• Operate and troubleshoot analytical instruments including HPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus
  , and related laboratory equipment.
• Conduct cleaning validation sample analysis and support validation activities.
• Provide analytical support for vendor qualification and material approval processes.
• Review and investigate OOS (Out of Specification), OOT (Out of Trend), and laboratory investigations
  .
• Prepare, review, and update SOPs, STPs, specifications, and analytical documents
  .
• Support batch release activities in coordination with QA and manufacturing teams.
• Ensure compliance with cGMP, regulatory guidelines, and data integrity requirements
  .
• Maintain laboratory documentation and ensure audit readiness.

• M.Sc. /
  
  B.Pharm / M.Pharm
• Minimum 8 years of QC experience in sterile / injectable manufacturing (mandatory)
• Strong knowledge of regulatory requirements (USFDA, MHRA, EU GMP preferred)
• Good analytical troubleshooting and documentation skills