Quality Auditor - Scientific - I

WorkLLama

Elkhorn Precinct (NE)

On-site

USD 30,000 - 58,000

Part time

7 days ago
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Job summary

WorkLLama is seeking a QA Contractor in Elkhorn, NE to review and release batch records across departments while ensuring compliance with cGMP, USDA, and animal health standards.

The role blends office-based quality work with on-floor exposure in manufacturing areas, collaborating with Upstream/Downstream IPTs and QA leadership. Strong attention to detail and problem-solving are essential.

Qualifications

  • Minimum education: High School Diploma (or equivalent).
  • Preferred: Bachelor’s degree in Microbiology, Chemistry, or a related scientific discipline.

Responsibilities

  • Review completed production batch documents across multiple departments to support batch releases.
  • Track and prioritize document reviews based on target release dates and provide status updates to upstream/downstream teams.
  • Provide documentation guidance from a quality compliance perspective, leveraging knowledge of cGMP, animal health standards, and USDA regulations.
  • Support raw material and printed packaging material reviews and releases.
  • Maintain detailed focus while reviewing paper batch records and assist with archival tasks.
  • Collaborate with IPTs and QA leadership to assist with investigations, compliance actions, and inspections.
  • Spend ~20% of time in manufacturing areas to learn processes and build relationships with production operators.
  • Serve as a backup for QA functions and cross-train across the QA team.
  • Manage short-term tasks and special projects with high organization and agility.

Skills

cGMP knowledge
QMS
Documentation review
SAP
Regulatory compliance
Investigations support
Cross-functional collaboration

Education

High School Diploma
Bachelor’s degree in Microbiology, Chemistry, or related field

Tools

SAP

Job description

Join a specialized and dynamic Quality Assurance team in Elkhorn, NE as a QA Contractor supporting animal health manufacturing operations. In this role, you will play a critical part in ensuring quality and compliance, primarily focusing on the detailed review and batch record release of completed production documents across multiple departments. Operating in a clean manufacturing facility, you will bridge office-based compliance work with hands‑on engagement in manufacturing areas, collaborating closely with Upstream and Downstream Integrated Process Teams (IPTs), QA colleagues, and regulatory inspectors. We are looking for a detail-oriented, organized professional with strong critical thinking, problem-solving skills, and disciplined judgment who thrives in a collaborative environment where Safety and Quality are primary values.

Responsibilities
  • Review completed production batch documents across multiple departments to support ongoing manufacturing operations and batch releases.
  • Track and prioritize document reviews based on target release dates, providing regular review status updates to both upstream and downstream teams.
  • Provide documentation guidance from a quality compliance perspective, leveraging knowledge of cGMP, local and global Animal Health standards, and USDA regulations.
  • Support raw material and printed packaging material reviews and releases.
  • Maintain detailed focus while reviewing paper batch records for significant portions of the workday and assist with document archival tasks.
  • Work closely with Upstream and Downstream IPTs and QA leadership to assist with investigations, compliance actions, and regulatory or off-site agency inspections.
  • Spend approximately 20% of the time in manufacturing areas to learn processes, evaluate compliance, and build strong relationships of trust with production operators and management.
  • Serve as a backup for various Quality Assurance functions and systems, seeking opportunities to cross‑train across the QA team.
  • Manage short-term tasks, special projects, and other duties as assigned by the QA Manager and Quality Director with high organization and agility.
  • Balance operational perspectives across Planning, QA, and Production using strong leadership behaviors and principles of inclusion.
Education
  • Minimum Requirement: High School Diploma (or equivalent).
  • Preferred Requirement: Bachelor’s degree in Microbiology, Chemistry, or a similar scientific discipline.
Experience
  • Minimum Requirement: High School Diploma with a minimum of 3 years of general work history OR 1 year of experience in a similar industry.
  • Preferred Experience & Skills:
  • Familiarity and/or experience with vaccine manufacturing and testing.
  • Experience with USDA and/or FDA regulations, standards, and inspections.
  • Hands‑on experience with cGMP and Quality Management Systems (QMS).
  • Familiarity and/or experience with SAP or similar enterprise software systems.
Additional Information
  • Work Location: Elkhorn, NE (On‑site; primarily office setting ~80%, with regular presence in clean manufacturing areas ~20%).
  • Shift Schedule: First Shift (Flexible start time between 6:30 AM and 8:00 AM CST).
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