Quality Control Analyst

Our client is seeking an experienced QC Analyst to support laboratory investigations, root cause analysis, and CAPA activities within a cGMP-regulated environment. This is a great opportunity for a quality-focused professional looking to take ownership of critical investigations and work closely with cross-functional teams.

Responsibilities

• Lead and document QC and OOS investigations from initiation through closure.
• Conduct root cause analysis using 6M, 5 Why, and Fishbone methodologies.
• Identify CAPAs and support corrective actions to prevent recurring issues.
• Collaborate with QC, QA, customers, and cross-functional teams to meet investigation deadlines and quality commitments.
• Ensure investigations comply with cGMPs, SOPs, and global quality standards.
• Track laboratory metrics and identify opportunities to reduce analyst errors, equipment failures, and testing issues.
• Provide investigation updates to management and support critical laboratory investigations.

Qualifications

• Bachelor’s degree in Chemistry or a related scientific discipline with 6+ years of QC laboratory experience, or an equivalent combination of education and experience.
• Experience with investigations, root cause analysis, investigation writing, and CAPA identification.
• Strong knowledge of cGMP requirements and laboratory quality practices.
• Excellent problem-solving, documentation, and communication skills.

INDBH