Associate Manager - Quality Control

Job Description:

Responsibilities

• Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records.
• Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories.
• Support media preparation, Bio ball culture handling, and conduct microbiology-related investigations.
• Perform testing on various samples, manage Laboratory Information Management System builds, and review laboratory data.
• Serve on cross-functional teams, conduct safety inspections, participate in investigations, recommend corrective actions, and train junior colleagues. 

Qualification & Experience

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
• Strong technical skills in method validation and testing
• Experience in microbiological testing of water
• Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
• Detail-oriented with robust knowledge of quality systems
• Familiarity with research unit clinical and analytical laboratory environments
• Effective written and verbal communication, as well as interpersonal skills