Job Title: QC Inspection Specialist

Job Description

The QC Inspection Specialist (QMCS / Validation Specialist) supports computerized system validations and broader validation activities across pharmaceutical manufacturing operations. Working closely with Quality, Manufacturing, Engineering, Facilities, and Operations teams, this role ensures equipment, systems, and processes comply with current Good Manufacturing Practices (cGMP) in a regulated environment. It is well suited for professionals in computer science, software, engineering, chemistry, or validation who enjoy a fast-paced manufacturing setting and are motivated to drive compliance, quality, and operational excellence.

Responsibilities

• Manage the lifecycle of computerized systems in a regulated pharmaceutical manufacturing environment, ensuring ongoing compliance and validated state.
• Lead and support computerized system validation (CSV) activities for manufacturing, laboratory, and automation systems.
• Author, review, and execute IQ/OQ/PQ protocols and other validation documentation for equipment, systems, and processes.
• Develop, implement, and maintain validation procedures, policies, and standards aligned with cGMP requirements.
• Support equipment qualification, system implementation, and change control activities, including documentation and execution.
• Conduct risk assessments, gap analyses, and traceability exercises to identify and mitigate validation and compliance risks.
• Review, revise, and update standard operating procedures (SOPs) and manufacturing process documentation to reflect validated states and regulatory expectations.
• Collaborate with Quality, Engineering, Manufacturing, Facilities, and Operations teams to plan, coordinate, and execute validation projects.
• Support CAPA investigations by contributing to root cause analysis, defining corrective and preventive actions, and maintaining validated status of systems and equipment.
• Assist with internal and external audits and inspections by preparing documentation, addressing findings, and supporting compliance initiatives.
• Prepare clear and comprehensive validation reports, discrepancy reports, and technical documentation to support regulatory and quality requirements.
• Contribute to visual inspection and QC activities related to production and laboratory processes, ensuring product and process quality.
• Promote quality assurance best practices across production, laboratory, and inspection activities, reinforcing adherence to cGMP and internal standards.

Essential Skills

• Bachelor's degree in Engineering, Science, Computer Science, Software Engineering, Chemistry, or a closely related field.
• At least 5 years of validation experience in a pharmaceutical or manufacturing environment.
• Demonstrated experience working within cGMP-regulated environments and applying regulatory guidance to daily operations.
• Hands-on experience with computerized system validations (CSV) in manufacturing or laboratory settings.
• Strong technical writing and documentation skills, including authoring protocols, reports, and SOPs.
• Proficiency with Microsoft Office applications for documentation, data analysis, and reporting.
• Experience working with quality assurance processes, QC inspection, SOP development, and production support in a regulated environment.

Additional Skills & Qualifications

• Experience validating laboratory or manufacturing equipment, including automation systems.
• Knowledge and practical experience with IQ/OQ/PQ execution for equipment and computerized systems.
• Familiarity with CAPA, Change Control, and Risk Assessment processes in a pharmaceutical or manufacturing context.
• Experience with pharmaceutical manufacturing equipment and related laboratory systems.
• Strong project coordination skills, including planning, prioritizing, and tracking validation activities.
• Effective stakeholder management skills with the ability to collaborate across Quality, Engineering, Manufacturing, Facilities, and Operations.
• Exposure to visual inspection, laboratory QC, and production processes in a pharmaceutical setting.

Work Environment

This role operates within a pharmaceutical manufacturing environment that produces a wide range of biological extracts for diagnostic testing and therapeutic treatment of allergy, as well as supplies to support immunotherapy practices. The setting is highly regulated, cGMP-driven, and quality-focused, with close collaboration among Quality, Manufacturing, Engineering, Facilities, and Operations teams. Work involves interaction with laboratory and manufa