Quality Auditor - Scientific - I (Assistant)

Nesco Resource•Elkhorn, NE

11h•Onsite

About The Position

The Quality Auditor supports manufacturing operations and is primarily responsible for reviewing completed production batch documents across multiple departments. The role provides documentation guidance from a quality-compliance perspective, applying knowledge of local and global Animal Health standards, USDA regulations, and cGMP. Document reviews are tracked and prioritized according to target release dates, and the auditor helps the IPT monitor review priorities and communicate status to upstream and downstream groups. The position also assists with document archival and the review and release of printed packaging and raw material components. Working closely with Upstream and Downstream IPTs and other Quality Assurance team members, the auditor provides quality support that may include assisting with inspections, investigations, and compliance actions assigned to the IPT. The role may serve as backup for other QA functions and assist with quality systems tasks such as deviations and change controls. The successful candidate is expected to develop competency across QA functions and systems and contribute to projects and other responsibilities within the QA and manufacturing team. Short-term tasks and projects with varying urgency and difficulty may also be assigned. The position is based in a clean manufacturing lab environment. Approximately 80% of the work is in an office setting, with regular time in manufacturing areas to learn processes, evaluate compliance, and build relationships with production operators and management. The role requires sustained attention to detail when reviewing paper documents. The successful candidate brings critical thinking, problem-solving, and disciplined judgment, and works across Planning, QA, and Production while prioritizing safety and quality. Additional duties include participating in regulatory agency and off-site entity quality compliance inspections, as well as other tasks assigned by the QA Manager and Quality Director.

Requirements

High school diploma with at least 3 years of work history, or a high school diploma with 1 year of experience in a similar industry.
Ability to maintain detailed focus while reviewing paper documents for significant portions of the workday.
Critical-thinking, problem-solving, organizational, and disciplined-judgment abilities.
Ability to work with Planning, QA, and Production while prioritizing safety and quality.

Nice To Haves

Degree in microbiology, chemistry, or a similar scientific discipline.
Familiarity with or experience in vaccine manufacturing and/or testing.
Familiarity with or experience in USDA and/or FDA regulations and inspections.
Experience with GMP and Quality Management Systems.
Familiarity with or experience using SAP or similar systems.

Responsibilities

Review completed production batch documents across multiple departments.
Provide documentation guidance from a quality-compliance perspective, applying relevant Animal Health standards, USDA regulations, and cGMP knowledge.
Track and prioritize document reviews based on target release dates and help the IPT meet review targets.
Communicate review status regularly to groups upstream and downstream of document review.
Assist with document archival tasks.
Provide quality support to Upstream and Downstream IPTs, including assisting with inspections, investigations, and assigned compliance actions.
Support the review and release of printed packaging and raw material components.
Serve as backup for various QA functions and assist with quality systems tasks, including deviations and change controls.
Develop competency in multiple Quality Assurance functions and systems and assist with projects and responsibilities across the QA and manufacturing team.
Participate in quality compliance inspections conducted by regulatory agencies and off-site entities.
Perform other tasks assigned by the QA Manager and Quality Director.
Spend regular time in manufacturing areas to learn processes, evaluate compliance, and build relationships with production operators and management.