Clinical Manufacturing Investigator

4 days ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Clinical Manufacturing Investigator Role:

Lynkx Staffing LLC is seeking a skilled Clinical Manufacturing Investigator to join our team. As a Compliance Investigator, Clinical Manufacturing, you will investigate quality issues and implement corrective actions to ensure compliance.

Key Responsibilities:
• Lead life-cycle investigations to identify root causes of quality issues.
• Develop and implement preventative actions to prevent recurrence.
• Collaborate with cross-functional teams to develop and track CAPA plans.
• Analyze process data to identify improvement opportunities.
• Communicate effectively with stakeholders to ensure timely completion of tasks.

Requirements:
• BS degree in a Quality/Process related field.
• Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma.
• Root cause analysis experience preferred.
• Relevant IT skills.
• Strong analytical and problem-solving skills.
• Ability to work well in a cross-functional environment.

Estimated Salary: $80,000 - $105,000 per year.

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