Senior Specialist, Quality Control

Description

• Perform/review laboratory system lifecycle management, including risk-based approach system qualification/retirement for laboratory computerized systems, commissioning/decommissioning, system administration, periodic temperature mapping, and system periodic reviews, in accordance with approved procedures and standard lead time.
• Lead CAPEX and asset settlement process to ensure accuracy and completion within stipulated timeline.
• Lead and execute section and Quality improvement initiatives and other special projects, ensuring alignment with business goals and timelines.
• Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with cross-functional teams and above-site functions. This includes initiating alignments proactively, sharing expertise, and providing input to ensure alignment and consistency across the organization.
• Author/review Quality Notifications, lead root cause analysis and ensure effective implementation of related actions within the agreed timeframe.
• Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency and compliance.
• Identify opportunities and propose solutions to improve efficiency and compliance in processes, standards, and best practices within the team.
• Provide leadership, expert guidance and support to team members, acting as a go-to resource for problem-solving and decision-making.
• Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
• Act as backup to Reporting Manager, assist in daily operations and strategized planning to ensure all business and compliance requirements are met within stipulated timeline.
• Provides contractor oversight to support daily operations.
• Support and respond to audit requirements and findings.
• Any other duties as assigned by reporting manager.

Qualifications

• Degree in a relevant scientific or technical discipline (e.g., Chemistry, Biochemistry, Pharmaceutical Science, Engineering, IT with GxP experience).
• Minimum 6 years of applied professional work experience in Equipment Qualification and Computerized Systems Validation in a GMP-regulated environment.

Preferred

• Strong knowledge of laboratory system lifecycle management, calibration & maintenance, Quality mindset and Data Integrity.
• Work experience specifically in GMP regulated QC Laboratory or Lab Systems Support (e.g., LabX, Empower).
• Demonstrated experience in change and project management with ability to lead a cross-functional team.
• Experience in System Development Lifecycle (SDLC) and Lab equipment qualification (IQ/OQ) is preferred