Quality Specialist

Infotree Global Solutions; Salt Lake City (UT); On-site; USD 30,000 - 39,000; Full time

Job summary

Infotree Global Solutions is seeking a Quality Documentation Specialist to support the preparation, completion, and revision of nonconformance records using controlled Word templates and approved examples. You will work with manufacturing/quality data from internal systems in a high-volume environment.

The role requires accuracy in problem descriptions, containment details, part/lot numbers, and quantities.

Qualifications

• Associate degree or equivalent experience required.
• 1+ years of quality, manufacturing, regulatory, documentation experience.
• Experience in a regulated environment preferred.

Responsibilities

• Prepare and update nonconformance records using templates; tailor content to each event.
• Ensure accurately documented problem descriptions, containment, scope, part/lot numbers, quantities, and other fields.
• Navigate Oracle and other systems to retrieve manufacturing orders, inventory, traceability, and quality information; cross-check entries.
• Identify missing or unclear information; ask relevant personnel for clarification by email, Teams.
• Incorporate reviewer comments, manage revisions, and resubmit for review.
• Track records by status; meet productivity and quality expectations.
• Follow documentation procedures, data integrity practices, and access controls; escalate issues.

Skills

Microsoft Word

Templates

Data entry

Oracle

ERP systems

Attention to detail

Written communication

Education

Associate degree

Tools

Oracle

ERP systems

Microsoft Excel

Outlook

Teams

Job description

Job title: "Quality Documentation Specialist”

Job location: Salt Lake City, UT 84123

Duration: 3 months

Job Summary: 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.
• Incorporate reviewer comments quickly and accurately, manage revision cycles, and resubmit documents for review.
• Track assigned, in-progress, awaiting-input, and completed records; meet agreed productivity and quality expectations.
• Follow applicable documentation procedures, data integrity practices, and access controls; escalated 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.
• Excellent attention to detail, organizational skills, logical reasoning, and written communication.
• Comfortable performing repetitive, high-volume work with sustained accuracy and responsiveness to feedback.
• Proactive, approachable, and willing to walk to the appropriate department to resolve questions when necessary.
• Ability to follow defined instructions and work independently after training.
• General understanding of a plastic component structure and role of product specifications
• 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.
• Strong verbal and written communication skills
• Experience in quality documentation, document control, manufacturing administration, or quality assurance support.

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.
• Experience following established procedures, workflows, decision trees, or quality system requirements.
• Experience working in a regulated environment is preferred but not required.