Preclinical Quality Engineer III - Audit & CAPA Lead

Us Tech Solutions; Saint Paul (MN); On-site; USD 90,000 - 92,000; Full time

Job summary

US Tech Solutions in Saint Paul, MN, is seeking a Preclinical Laboratory Quality Engineer to provide quality support for preclinical testing laboratories, suppliers, and studies worldwide, ensuring compliance with ISO 13485, 21 CFR 820, 21 CFR 58, ISO 10993, and ISO/IEC 17025.

The role conducts internal and external quality reviews, participates in CAPA, audits vendors, and supports inspection readiness, with a 12-month contract and hourly pay of $65–$67.

Qualifications

• Bachelor’s degree in chemistry or related life sciences discipline.
• Strong technical and quality knowledge of ISO/IEC 17025, ISO 13485, and/or 21 CFR 58.
• Strong verbal and written communication skills, both technical and conversational.
• Minimum of 3 years' experience in a technical role.

Responsibilities

• Support laboratory functions to maintain compliance with applicable regulations and standards, validated methods, and internal policies, procedures, and work instructions, while promoting continuous inspection readiness.
• Collaborate with quality management and laboratory management on process improvement initiatives, quality trends, and continuous improvement projects.
• Conduct internal and external quality assurance audits of systems, testing laboratories, procedures, and controls used in testing activities under applicable regulations and standards.
• Plan, schedule, and conduct vendor audits.
• Partner with global preclinical teams and Strategic Sourcing regarding new vendor requests and ongoing vendor needs.
• Evaluate the adequacy and compliance of systems, operations, and practices through facility- and process-based audits and quality monitoring activities.
• Assess the accuracy, validity, and overall quality of preclinical study data.
• Communicate final results of quality reviews and audits to management and technical staff.
• Write and publish audit and quality review reports, obtain appropriate approvals, and distribute findings to responsible stakeholders.
• Oversee follow-up of corrections and corrective actions, elevate overdue items, and support timely closure.
• Support or lead assigned quality projects and initiatives.
• Track audits and responses, support document review activities, and maintain appropriate records.
• Contribute to the development and continuous improvement of quality procedures and processes.
• Assist laboratories in preparation for accrediting body, notified body, FDA, or other regulatory inspections.
• Support the preclinical organization in meeting Quality System requirements.
• Support the CAPA process in partnership with CAPA owners.
• Support compliance review meetings in accordance with site procedures.

Skills

Quality Assurance

ISO 13485

GLP (21 CFR 58)

Auditing

CAPA

Vendor Audits

Education

Bachelor's degree in chemistry or related life sciences

Job description

US Tech Solutions in Saint Paul, MN, is seeking a Preclinical Laboratory Quality Engineer to provide quality support for preclinical testing laboratories, suppliers, and studies worldwide, ensuring compliance with ISO 13485, 21 CFR 820, 21 CFR 58, ISO 10993, and ISO/IEC 17025.

The role conducts internal and external quality reviews, participates in CAPA, audits vendors, and supports inspection readiness, with a 12-month contract and hourly pay of $65–$67.