QC Specialist, Equipment Management

Legend Biotech is seeking QC Specialist, Equipment Management as part of the Quality team based in Raritan, NJ. 

Role Overview

The QC Specialist, Equipment Management is responsible for equipment lifecycle management and Quality Control (QC) systems administration.

Key Responsibilities  

• Develop User Requirement Specifications (URS) and oversee the management of equipment qualifications.
• Provide support for data integrity assessments within the laboratory.
• Take the lead in managing Equipment Lifecycle Management processes, including overseeing change control procedures.
• Document and manage records for corrective and preventative actions, ensuring compliance with regulatory standards.
• Draft, review, and approve Standard Operating Procedures (SOPs) for equipment operation.
• Conduct regular reviews of system audit trails / periodic review to ensure data integrity and compliance.
• Manage equipment access rights and perform periodic reviews to maintain security protocols.
• Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and CSV (e.g., GAMP 5, USP <1058>, 21 CFR Part 210/211, etc.)
• Utilize troubleshooting skills to address and resolve issues related to analytical equipment functionality.
• Provide support during both internal and regulatory audits, ensuring adherence to established procedures and guidelines.
• Collaborate with Quality Systems, IT, and site facilities to support ongoing instrument and applications troubleshooting, maintenance, retirement, and change management.
• Interact with QC Analysts to nurture open dialogue regarding equipment metrology, maintenance, calibration, and repairs.

Requirements

• Minimum of Bachelor's or equivalent University degree required
• Minimum three (3) years of relevant work experience
• Experience in a Regulated Quality environment and/or Engineering Equipment Development environment
• Experience with IQ, OQ, and PQ
• Capability to creatively problem-solve and troubleshoot, develop improvement ideas, and independently implement associated solutions with minimal guidance as a proactive change agent.
• Excellent written and verbal communication skills with the ability to communicate clearly and concisely with all levels.
• Experience with equipment purchase, CSV, metrology, calibration, and/or maintenance
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory.
• Experience developing content for Validation Life Cycle documents (e.g., Master Validation Plan, User Requirements, Design Specification, Test Protocols (IQ/OQ/PQ), Test Summary Reports, Data Integrity Assessments, and/or Traceability Matrix)