ARD & QC Laboratory Operations Leader

NJ Bio, Inc.; Princeton (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

NJ Bio, Inc. is seeking an ARD & QC Manager, Laboratory Operations to lead and manage diverse laboratory functions, ensuring efficiency and regulatory compliance in a cGMP environment. You will supervise QC teams and partner with management/vendors on equipment qualification.

Responsibilities include developing SOPs, conducting internal EHS self-inspections, managing inventory, coordinating outsourced testing, and driving CAPAs and OOS investigations while maintaining GDP documentation.

Qualifications

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• Minimum 3 years of QC laboratory experience.
• Experience with EHS and cGMP compliance.
• Willingness to work outside normal business hours as needed.

Responsibilities

• Perform work safely and in compliance with EHS and cGMP guidelines.
• Lead and train quality control teams.
• Work with management and vendors to acquire, install, and qualify new equipment.
• Serve as primary contact for negotiation of quotes, service agreements, and contracts.
• Manage and schedule outsourced analytical and metrology testing.
• Develop SOPs and SOPs for calibration and OQ of equipment.
• Develop qualification/validation protocols for software.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Manage lab chemicals and consumables inventory.
• Lead internal self-inspections for safety and cGMP compliance.
• Prepare SOPs, protocols, and reports as needed.
• Conduct OOS risk assessment and root cause investigations; assist management.
• Write deviations, change controls, and CAPAs; assist management.
• Document work in lab notebooks/logbooks per GDP.

Skills

Microsoft Office

cGMP/ICH/USP/Ph.Eur

Analytical instruments

Communication

Interpersonal skills

Independent & collaborative work

Analytical thinking

Planning & time management

Availability for flexible hours

Education

BS/MS/PhD in chemistry/biology/biochemistry

BS with 6+ years experience

MS or higher with 4+ years experience

Job description

NJ Bio, Inc. is seeking an ARD & QC Manager, Laboratory Operations to lead and manage diverse laboratory functions, ensuring efficiency and regulatory compliance in a cGMP environment. You will supervise QC teams and partner with management/vendors on equipment qualification.

Responsibilities include developing SOPs, conducting internal EHS self-inspections, managing inventory, coordinating outsourced testing, and driving CAPAs and OOS investigations while maintaining GDP documentation.