Qualifications

• 7+ years in pharmaceutical industry and quality systems
• 3+ years in QC laboratory environment
• Bachelor's Degree in life sciences, ideally chemistry
• Background in regulated manufacturing with regulatory authority inspections
• Strong written and verbal communication skills
• Experience in structured process improvement initiatives
• Oversight and auditing experience in laboratory settings
• Proficient in reviewing raw data and test results

Responsibilities

• Support QC functions for GXP activities in cGMP manufacturing
• Manage laboratories for finished product testing
• Streamline processes for improved efficiency
• Review and approve certificates of analysis from contract labs
• Handle deviations related to QC tasks
• Investigate Out of Specification (OOS) and Out of Trend (OOT) issues
• Assist in audits of contract laboratories alongside Quality Assurance
• Review specifications for raw materials and finished products
• Conduct trend analysis for product specifications
• Prepare and review regulatory filings
• Create and approve Standard Operating Procedures (SOPs)

Benefits

• Collaborative work environment
• Opportunities for professional development
• Engagement in process improvement
• Contribution to meaningful work in healthcare
• Access to cutting-edge laboratory technologies