Manager, QC Lab Remediation
$105,000–$131,200 year
On-site · Rensselaer, New York, United States
Job Summary
Manager, QC Lab Remediation leads the QC laboratory remediation program and drives continuous improvement to maintain regulatory compliance while implementing CAPA plans. The role oversees the QC lab’s systems, coordinates with QC supervisors and QC Manager on regulatory inspections and customer audits, tracks performance metrics, leads the LIMS implementation, and develops training programs and trainers. The position focuses on identifying gaps, implementing compliant solutions, updating analytical methods and procedures, and driving systemic CAPAs in a GMP environment.
Required Qualifications
- Bachelor’s Degree in Chemistry or relevant field
- Minimum of 5 years of relevant related work experience
- 2 years in a team leadership role
- Investigations experience including root cause analysis, writing, and CAPA identification
- Good understanding of GMP requirements for QC operations
- Previous experience managing a QC team in a commercial product GMP environment
- Experience in cGMP QC environment
- Knowledge of FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
- Background check and drug screen
- Occupational Health Screening may be required
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