Website ClifyX, INC
ClifyX, INC
Company : ClifyX, INC
The Quality Control (QC) IT Engineer is responsible for ensuring the integrity, reliability, and compliance of IT systems and instruments used within the QC Laboratory environment. This role supports the implementation, maintenance, and qualification of QC instruments and software, with a strong emphasis on Good Manufacturing Practice (GMP) controls. The QC IT Engineer collaborates closely with laboratory staff, quality assurance, and IT teams to maintain the highest standards of product quality and regulatory compliance.
Key Responsibilities
• GMP Controls: Implement and maintain IT controls in alignment with GMP regulations. Ensure all QC software and instruments comply with current regulatory standards and company policies.
• QC Software Support: Administer, troubleshoot, and upgrade laboratory software systems (e.g., LIMS, CDS, Data Acquisition Systems). Provide user support, manage software configurations, and ensure data integrity.
• QC Instrument Support: Maintain and support computerized laboratory instruments (e.g., HPLCs, GCs, spectrophotometers). Collaborate with vendors and instrument specialists for installation, calibration, and repair activities.
• Qualification Support: Lead or assist in Computer System Validation (CSV), equipment qualification, and periodic review processes. Generate and review technical documentation, protocols, and reports.
• Compliance & Documentation: Ensure all activities are documented in accordance with GMP and data integrity requirements. Participate in audits and inspections, providing technical information as needed.
• Continuous Improvement: Identify and implement improvements to QC processes, IT infrastructure, and data management practices to enhance efficiency and compliance.
• Training: Develop and deliver training materials for laboratory personnel on IT systems, data integrity, and compliance best practices.
Required Qualifications
• Bachelor's degree in Computer Science, Information Technology, Engineering, or a related field.
• Minimum 3 years of experience in an IT support role within a pharmaceutical, biotechnology, or regulated laboratory environment.
• Proven experience with GMP regulations, QC software (e.g., LIMS, CDS), and laboratory instruments.
• Hands-on experience in computer system validation (CSV) and equipment qualification.
• Strong understanding of data integrity principles and regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11).
• Excellent troubleshooting, analytical, and communication skills.
Preferred Qualifications
• Advanced degree or certifications in relevant fields (e.g., GAMP, ITIL, CompTIA).
• Experience with electronic batch records, MES, or other manufacturing IT systems.
• Familiarity with project management methodologies and tools.
Key Competencies
• Attention to detail and commitment to quality.
• Ability to work both independently and collaboratively in a cross-functional team.
• Strong organizational and documentation skills.
• Adaptability in a fast-paced, regulated environment.