Quality Control Scientist

Requirements

• Optimize and troubleshoot QC methods to enhance performance, consistency, and efficiency.
• Support method qualification, validation, and lifecycle management per regulatory expectations (ICH, USP, FDA).
• Perform data trending and analysis to monitor assay performance and detect method variability or drift.
• Collaborate with Analytical Development for seamless method transfers and onboarding of new assays into the QC laboratory.
• Draft and review method SOPs, validation protocols/reports, and technical documentation.
• Contribute to investigations, CAPAs, and continuous improvement initiatives within the QC function.
• Evaluate and implement new technologies or instrumentation to improve assay robustness and throughput.
• Provide technical documentation and SME input for regulatory inspections and audits.
• Participate in risk assessments, gap analyses, and change control activities related to QC methods.
• Train QC analysts on new or optimized assays to ensure consistent and compliant execution.
• Author and review technical reports, method development summaries, and QC method lifecycle documents.
• Maintain GMP documentation and laboratory practices with a strong lab-based presence.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance