IT Quality Specialist

skellig; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical automation company is seeking an IT Quality Specialist to ensure compliance and continuous improvement of computerized systems. The ideal candidate will have over 3 years of IT Quality experience in the pharmaceutical industry, strong understanding of GxP regulations, and excellent technical writing skills. This role involves managing CAPAs, reviewing validation deliverables, and collaborating with cross-functional teams.

Qualifications

• 3+ years of experience in IT Quality or related roles within the pharmaceutical industry.
• Strong understanding of GxP regulations.
• Hands-on experience with CAPA/deviation management.

Responsibilities

• Draft and manage periodic reviews of computerized systems.
• Manage CAPAs and deviations with effective corrective actions.
• Review validation deliverables for compliance with GxP.

Skills

IT Quality

Computer System Validation (CSV)

GxP regulations

Analytical skills

Technical writing

Education

Bachelor’s degree in Computer Science, Information Systems, Life Sciences, Engineering

Tools

Veeva QualtiyDocs

TrackWise

Job description

Specialist providers of pharmaceutical automation, process and project controls.

Skellig was founded to radically improve upon the way automation, process, and project controls are provided. It’s a goal that is grounded in efficiency, transparency, and our client’s total peace of mind — this is the vision behind everything we do.

At Skellig Automation, we empower great people to do great work in the Life Sciences industry. Our engineers provide premier automation services with one common goal: to make medicine more affordable and accessible for all by reducing the cost of manufacturing. We work alongside other industry leaders in laying the foundation for true technological innovation and guiding our partners towards modern process solutions.

Whether working within the traditional automation stack or championing Industry 4.0 systems, Skellig has a place for creative engineers with a passion for bringing the Life Sciences into the future.

Position Summary

The IT Quality Specialist is responsible for ensuring the compliance, integrity, and continuous improvement of computerized systems within the pharmaceutical environment. This role focuses on executing and maintaining IT Production Operations and Technology (PO&T) department deliverables, including periodic reviews, CAPA and deviation management, user access review, validation document review, and the development of standard operating procedures (SOPs), work instructions (WIs), and job aids. The IT Quality Specialist collaborates with cross-functional teams to maintain adherence to regulatory requirements (e.g., FDA, EMA, GxP) and internal quality standards.

Key Responsibilities

• Draft, execute, and manage computerized system periodic reviews in accordance with regulatory and company requirements.
• Manage CAPAs and deviations, ensuring timely investigation, root cause analysis, and effective corrective/preventive actions.
• Review and approve validation deliverables (e.g., URS, IQ/OQ/PQ, test scripts, summary reports) for compliance with GxP and data integrity requirements.
• Draft, revise, and maintain SOPs, Work Instructions, and job aids to ensure alignment with current regulatory expectations and internal processes.
• Partner with IT, Quality, and Business stakeholders to support audits, inspections, and continuous improvement initiatives.
• Monitor trends in IT quality events and provide input into risk assessments and process improvements.
• Ensure documentation practices are consistent with data integrity principles (ALCOA+).

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Life Sciences, Engineering, or related discipline (or equivalent experience).
• 3+ years of experience in IT Quality, Computer System Validation (CSV), or related Quality roles within the pharmaceutical or life sciences industry.
• Strong understanding of GxP regulations (21 CFR Part 11, Annex 11, FDA, EMA, ICH guidelines).
• Hands-on experience with CAPA/deviation management systems and periodic review processes.
• Excellent technical writing skills for SOPs, WIs, and job aids.
• Ability to work cross-functionally and communicate effectively with both technical and non-technical stakeholders.
• Strong analytical and problem-solving skills with attention to detail.

Preferred Qualifications

• Experience with electronic systems such as Veeva QualtiyDocs, TrackWise, or equivalent.
• Familiarity with audit/inspection management.
• Knowledge of pharmaceutical manufacturing and laboratory systems (e.g., LIMS, MES, ERP).

Skellig is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment and encourage applications from all qualified candidates.