ARD & QC Manager, Laboratory Operations

The ARD & QC Manager, Laboratory Operations will lead and manage various laboratory functions to ensure operational efficiency and regulatory compliance. Key responsibilities include the following:

• Equipment and software management
• Supervise, train, and mentor junior QC scientists and associate scientists
• Develop and implement corrective and preventive actions
• Chemical and consumables inventory management
• Internal safety and cGMP self-inspections
• Sample management, including outsourced testing
• EHS management

The incumbent works cross-functionally with internal departments and external resources on ARD/QC related issues. The ARD & QC Manager, Laboratory Operations, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Responsibilities:

• Perform all work in a safe and compliant manner in accordance with EHS best practices 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 work outsourced to third-party analytical and metrology service providers.
• Develop procedures and SOPs for calibration and OQ of equipment
• Develop protocols for qualification/validation of software
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Manage lab chemicals and consumables including tracking and replenishing inventory.
• Lead internal self-inspections to ensure safety and cGMP compliance
• Prepare standard operating procedures (SOPs), protocols, reports, etc. as needed.
• Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
• Write deviations, change controls, and CAPAs, and/or assist management with these documents.
• Document work in laboratory notebooks and logbooks according to organizational GDP policies.