Quality Auditor - Scientific - I (Assistant)

Nesco Resource•Elkhorn, NE

23h•Onsite

About The Position

The Quality Auditor supports manufacturing operations, primarily by 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. Reviews are tracked and prioritized according to target release dates, with regular status communications to groups upstream and downstream of document review to help the IPT meet target dates. The role also assists with document archival and reviews of raw materials and printed materials, including support for 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 position participates in regulatory-agency and off-site quality compliance inspections and may serve as a backup for various QA functions. The successful candidate will seek opportunities 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 of varying urgency and difficulty may also be assigned. The role 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 work requires sustained attention to detail while reviewing paper documents. Critical thinking, problem solving, disciplined judgment, organization, and the ability to navigate the perspectives of Planning, QA, and Production are important. Safety and Quality are primary values.

Requirements

High school diploma and a minimum of 3 years of work history, or a high school diploma and 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, disciplined judgment, and organization.
Ability to work across the perspectives of 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 with USDA and/or FDA regulations and inspections.
Experience in 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 according to target release dates and help the IPT prioritize reviews to meet target dates.
Communicate review status regularly to groups upstream and downstream of document review.
Assist with document archival tasks.
Assist with raw material and printed material reviews, including review and release of printed packaging and raw material components.
Work with Upstream and Downstream IPTs and other QA team members to provide quality support.
Assist with inspections, investigations, and compliance actions assigned to the IPT.
Participate in quality compliance inspections conducted by regulatory agencies and off-site entities.
Become a backup for various QA functions within the team.
Contribute to QA and manufacturing projects and other responsibilities, including short-term assigned tasks.
Spend regular time in manufacturing areas to learn processes, evaluate compliance, and build relationships with production operators and management.