QC Analyst / QC Systems Specialist

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading technology solutions provider in Singapore seeks experienced QC Analysts/QC Systems Specialists. The role involves supporting QC systems management and ensuring data integrity compliance. Candidates should have 5-8 years of experience in QC laboratories, with hands-on expertise in Empower and LabX. This position offers the opportunity to collaborate with cross-functional teams and ensure compliance with regulatory guidelines.

Qualifications

• 5-8 years of experience in QC laboratories within pharmaceutical/biotech.
• Hands-on expertise with Empower and LabX is mandatory.
• Strong background in computer system validation and equipment qualification.

Responsibilities

• Provide support for QC computerized systems including Empower and LabX.
• Manage system configuration, administration, and troubleshooting.
• Perform system qualification activities in accordance with GxP.

Skills

Empower

LabX

Computer system validation

Data integrity

Stakeholder management

Tools

HPLC

GC

UV

Karl Fischer

Job description

We are looking for experienced QC Analysts / QC Systems Specialists to support laboratory operations, QC systems management, and data integrity compliance. The ideal candidate will bring strong hands-on experience with Empower, LabX, and other QC support systems, along with solid understanding of configuration, qualification, and regulated laboratory environments.

Key Responsibilities

• Provide day-to-day support for QC computerized systems including Empower and LabX. Manage system configuration, administration, and troubleshooting to ensure uninterrupted QC operations.

• Perform system qualification activities (IQ/OQ/PQ) in accordance with GxP and data integrity requirements.

• Support change controls, deviation investigations, and CAPAs related to QC systems.

• Execute periodic reviews, access management, and audit readiness activities.

• Collaborate with QC, QA, IT, vendors, and cross-functional teams for system upgrades, enhancements, and validation work.

• Ensure compliance with 21 CFR Part 11, ALCOA+ principles, and applicable regulatory guidelines.

• Prepare and maintain system documentation, SOPs, configuration specifications, and validation deliverables.

• Provide user training, onboarding, and technical guidance to QC laboratory personnel.

• Support integration of QC instruments and data workflows as required.

Required Skills & Experience

• 5-8 years of experience in QC laboratories within pharmaceutical/biotech or regulated manufacturing.

• Hands‑on expertise with Empower (mandatory) and LabX (mandatory).

• Proven experience in QC system support, configuration, and troubleshooting.

• Strong background in computer system validation (CSV) and equipment qualification.

• Solid understanding of GxP, data integrity, and ALCOA+ guidelines.

• Experience supporting QC instrument systems (HPLC, GC, UV, Karl Fischer, etc.) is an advantage.

• Familiarity with LIMS, SDMS, or other laboratory informatics platforms is a plus.

• Strong documentation and stakeholder‑management skills.