Quality Specialist III, Document Control and Training

Scorpion Therapeutics; Madison (WI); On-site; USD 78,000 - 98,000; Full time

Benefits offered by this job

Excellent benefits package

Competitive salary

Job summary

Scorpion Therapeutics in Madison, WI is seeking an experienced professional to serve as an individual contributor supporting day-to-day execution of controlled documentation and training compliance within the Quality Assurance function. You will process and maintain controlled documents, quality records, and training records in the eQMS and LMS, ensuring accuracy, completeness, and regulatory compliance.

Responsibilities include supporting document control lifecycle, audit readiness, and the

Qualifications

• BS/BA in an applicable scientific field (e.g., chemistry, biology, biochemistry).
• Minimum 5 years’ experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization writing and maintaining documents.
• Ability to follow company procedures, work instructions, and policies.
• Ability to multitask and prioritize work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Strong organizational skills; ability to manage multiple tasks, prioritize workload, and meet competing deadlines.

Responsibilities

• Document Control and Records Management: Support document formatting, metadata entry, routing, approval workflows, effective date coordination, periodic review activities, and controlled document lifecycle maintenance.
• Maintain organized, audit-ready document control files, including effective documents, superseded/obsolete records, document change records, and supporting documentation.
• Assist with preparation of document control packages for internal audits, client audits, regulatory inspections, and document change control activities.
• Assist with controlled copy management, document distribution, retrieval, archival, and record retention.
• Assist with development/revision/maintenance of document control work instructions and SOPs.
• Support formatting and routing of corporate policies through approval workflows; coordinate periodic review timing with Legal, Health Care Compliance, IS&I, and stakeholders.

Skills

Attention to detail

Communication

Multitasking

Organizational skills

Documentation

Education

BS/BA in science

Tools

Veeva/eQMS

LMS software

Adobe Acrobat

Microsoft Word

PowerPoint

Excel

Job description

The Position

Serve as an individual contributor supporting the day-to-day execution of controlled documentation and training compliance activities within the Quality Assurance function. Process and maintain controlled documents, quality records, and training records within the eQMS and learning management system, ensuring accuracy, completeness, and compliance with applicable regulatory requirements. Support the issuance, reconciliation, and review of applicable controlled documents to ensure traceability of applicable GxP documentation.

Responsibilities

Document Control and Records Management

• Support document formatting, metadata entry, routing, approval workflows, effective date coordination, periodic review activities, and controlled document lifecycle maintenance.
• Support issuance, reconciliation, and review of controlled documents and completed records to verify completeness and compliance with GDocP requirements.
• Maintain organized, audit-ready document control files, including effective documents, superseded/obsolete records, document change records, and supporting documentation.
• Support preparation of document control packages for internal audits, client audits, regulatory inspections, and document change control activities.
• Assist with controlled copy management, document distribution, retrieval, archival, and record retention.
• Assist with development/revision/maintenance of document control work instructions and SOPs.
• Support formatting and routing of corporate policies through approval workflows; coordinate periodic review timing with Legal, Health Care Compliance, IS&I, and stakeholders.
• Perform additional duties as assigned.

Training Administration and Compliance

• Monitor training completion rates; identify at-risk or past-due training items and proactively elevate concerns.
• Assist in developing/updating training materials (slide decks, assessments, Read-and-Understand documents) for GxP and SOP-based programs.
• Support new hire orientation and classroom training activities.
• Compile/organize training completion data and generate routine compliance reports for management.
• Maintain training records in an organized, accurate, audit-ready state.
• Perform additional duties as assigned.

Requirements

• BS/BA in an applicable scientific field (e.g., chemistry, biology, biochemistry).
• Minimum 5 years’ experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization writing and maintaining documents.
• Ability to follow company procedures, work instructions, and policies.
• Ability to multitask and prioritize work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Strong organizational skills; ability to manage multiple tasks, prioritize workload, and meet competing deadlines.

Preferred

• Experience with an eQMS/eDMS platform (e.g., Veeva) and/or LMS software in a GxP-regulated environment.
• Working knowledge of GMP, GCP, and/or GLP regulations.
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Word, PowerPoint, and Excel.

Application instructions

• Candidates must have current, valid authorization to work in the country where this role is located.

Compensation/benefits

• Wisconsin pay range: $78,000 USD - $98,000 USD. Arrowhead provides competitive salaries and an excellent benefit package.