QC System Analyst II, Digital and Analytical Lab Solution

Role Summary

QC System Analyst II, Digital and Analytical Lab Solution

Role focused on managing equipment, GMP compliance, and continuous improvement within a regulated analytical/lab environment to ensure product quality and support clinical trials.

Responsibilities

• Ensure equipment is managed in accordance with governing procedures.
• Review completed equipment-related tasks in the CMMS.
• Launch change control records for document and/or equipment changes.
• Address equipment alarms (e.g., 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 and some equipment change control records.
• May assist with samples management, including physical sample/material handling, shipping/receiving, maintaining 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 GMP/cGMP regulated environment
• Required: Ability to troubleshoot analytical methods
• Required: Proficiency in entering computerized data
• Required: Experience working with simple scientific equipment
• Preferred: Demonstrated proficiency in computerized systems (Laboratory Information Management System)
• Preferred: Strong problem-solving and communication skills (written and verbal)
• Preferred: Ability to work effectively in a team, strong attention to detail
• Preferred: Experience with advanced laboratory techniques; ability to adapt to changing priorities and manage multiple tasks; strong organizational skills

Skills

• Analytical laboratory techniques
• GMP/cGMP compliance
• Change control and document management
• Equipment maintenance and calibration coordination
• Data entry and CMMS systems
• Problem solving and teamwork

Education

• High School Diploma or GED (with relevant experience as specified)

Additional Requirements

• On-site work location
• Physical/mental: N/A