QC System Analyst II, Digital and Analytical Lab Solution

Role Summary

QC System Analyst II, Digital and Analytical Lab Solution supports quality and compliance in equipment management, change control, and GMP/GxP processes within a regulated environment. The role involves ensuring proper equipment administration, documentation, and ongoing improvement to support safe and effective medicines.

Responsibilities

• Ensure equipment is managed in accordance with governing procedures.
• Review completed equipment-related tasks in the CMMS (computerized maintenance management system).
• Launch change control records for document and/or equipment changes.
• Address equipment alarms such as temperature excursions and assist in alarm investigations.
• Assist Equipment System Owners with purchasing equipment.
• Assist Equipment System Owners with periodic reviews of equipment and software.
• Perform equipment logbook reviews.
• Coordinate with Facilities for scheduling calibration, maintenance, and repairs.
• Evening, weekend, and/or on-call work may be required.
• May take lead role for some equipment periodic reviews.
• May take lead role for some equipment change control records.
• May assist with samples management including handling, shipping/receiving, chain of custody, and routine maintenance/cleaning of biosafety cabinets, freezers, and refrigerators.
• Apply GMP principles daily.
• Create and revise SOPs and other documents as needed.
• Identify and participate in continuous improvement projects.
• Maintain training to current standards and procedures on all assigned curriculums.
• Fully comply with health and safety procedures and practices.
• Author and own deviations as needed.
• Train other personnel.

Qualifications

• Required: High School Diploma or GED with 4+ years of relevant experience
• Required: Demonstrated analytical laboratory experience in a cGMP environment
• Required: Ability to troubleshoot analytical methods
• Required: Proficiency in entering computerized data
• Required: Experience working with simple scientific equipment

Preferred Qualifications

• Proficiency in computerized systems (Laboratory Information Management System)
• Strong problem-solving skills
• Excellent communication skills, both written and verbal
• Ability to work effectively in a team environment
• Strong attention to detail
• Experience with advanced laboratory techniques
• Ability to adapt to changing priorities and manage multiple tasks
• Strong organizational skills

Education

• No additional education requirements specified

Additional Requirements

• On Premise work location