QC Analyst / QC Systems Specialist

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.