Quality Documentation Specialist

ALOIS Solutions; Salt Lake City (UT); On-site; USD 50,000 - 65,000; Full time

Job summary

ALOIS Solutions in Salt Lake City, UT is seeking a Quality Documentation Specialist to support nonconformance record creation, revision, and data integrity in a high-volume environment. You will work with Oracle and ERP systems to pull manufacturing and quality data, prepare accurate descriptions, and escalate ambiguities to cross-functional teams while following GMP documentation standards.

This role emphasizes meticulous record keeping, template-driven workflows, and cross-department

Qualifications

• Associate degree or equivalent required.
• Quality, manufacturing, life sciences or related background encouraged.
• 1+ years in quality, manufacturing, regulatory, or documentation roles.
• Experience reviewing, documenting, and processing quality or regulatory records preferred.

Responsibilities

• Prepare, complete, and revise nonconformance records using standard Word templates and approved examples.
• Ensure accurate problem descriptions, containment, scope, part/lot numbers, quantities, and fields from verified data.
• Retrieve manufacturing orders, inventory, traceability, and quality information from Oracle and other authorized systems.
• Identify missing, conflicting, or unclear information and seek clarification from Quality, Manufacturing, Engineering, or Production teams.
• Follow documented procedures, data integrity practices, and access controls; escalate issues when needed.

Skills

Microsoft Word

Excel

Outlook

Teams

ERP navigation

Quality documentation

GMP knowledge

Attention to detail

Education

Associate degree

Tools

Oracle

ERP systems

Job description

• The Quality Documentation Specialist support the preparation, completion, and revision of nonconformance records using controlled Microsoft Word templates, previously approved examples, and manufacturing/quality data from authorized internal systems. This is a high-volume documentation execution role.
• Prepare and update nonconformance records using standardized Word templates and approved examples; adapt each record to its specific event rather than copying unverified content.
• Ensure an accurately documented problem descriptions, identified containment, scope of impact, part and lot numbers, quantities, and other required fields using verified source information and provided guidance.
• Navigate Oracle and other authorized systems to retrieve manufacturing orders, inventory, traceability, and quality information; cross-check entries for consistency.
• Identify missing, conflicting, or unclear information; proactively ask Quality, Manufacturing, Engineering, Production or other relevant personnel for clarification in person, by email, or through Teams.
• Follow applicable documentation procedures, data integrity practices, and access controls; escalation issues rather than making unsupported assumptions.

Knowledge, Skills & Qualifications:

• Strong Microsoft Word skills, including templates, tables, formatting, editing, and revision management; working knowledge of Excel, Outlook, and Teams.
• Ability to navigate ERP and other electronic systems and accurately transfer and reconcile information across sources.
• Ability to become knowledgeable in departmental procedures, GMP's, Specifications/Guidelines, product lines/processes and commodities
• Familiarity with the importance of clear documentation and guidelines governing medical devices.

Education and Experience:

• Associate degree or equivalent combination of education and relevant work experience required.
• Degree field is not required; candidates with backgrounds in quality, manufacturing, life sciences, business, technical disciplines, or related fields are encouraged to apply.
• 1+ years of experience in a quality, manufacturing, regulatory, compliance, documentation, or related operational environment.
• Experience reviewing, documenting, and processing quality or regulatory records preferred.