QC Lab Remediation Manager: Elevate GMP & CAPA

Curia Aalborg ApS; City of Rensselaer (NY); On-site; USD 106,000 - 136,000; Full time

Benefits offered by this job

Generous benefit options

Paid training

Vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

Job summary

Curia is seeking a Manager, Quality Control Lab Remediation in Rensselaer, NY to lead remediation initiatives for the QC lab and drive continuous improvement across systems and processes. The role requires coordinating with QC supervisors and the QC Manager to ensure inspection readiness and effective CAPA execution.

Responsibilities include leading the LIMS implementation, updating methods, and developing training programs to improve compliance with GMP, USP, EP, and FDA standards.

Qualifications

• Bachelor’s Degree in Chemistry or relevant field required.
• Minimum 5 years in QC-related work plus 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.

Responsibilities

• Establish and maintain QC lab remediation and continuous improvement.
• Work with QC supervisors and QC Manager to complete regulatory inspection and customer audit commitments.
• Trend QC lab performance metrics, identify areas of improvement and implement robust CAPAs.
• Lead QC lab inspection readiness plan.
• Perform gap assessments for Curia network regulatory inspectional observations and implement CAPAs.
• Develop a compliant training and qualification program in the lab and train the trainers.

Skills

GMP compliance

CAPA/Investigations

LIMS implementation

QC metrics & analytics

Regulatory inspections readiness

Team leadership

Education

Bachelor’s Degree in Chemistry or relevant field

Advanced degree in Chemistry or related field

Tools

LIMS

Job description

Curia is seeking a Manager, Quality Control Lab Remediation in Rensselaer, NY to lead remediation initiatives for the QC lab and drive continuous improvement across systems and processes. The role requires coordinating with QC supervisors and the QC Manager to ensure inspection readiness and effective CAPA execution.

Responsibilities include leading the LIMS implementation, updating methods, and developing training programs to improve compliance with GMP, USP, EP, and FDA standards.