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- Maintain organized and audit-ready document control files, including effective documents, superseded or obsolete records, document change records, and supporting documentation.
- Support preparation and organization 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 activities, as applicable.
- Assist with the development, revision, and maintenance of document control work instructions and SOPs, as directed.
- Support formatting and routing of corporate policies through approval workflows, and coordinate periodic review timing with Legal, Health Care Compliance, IS&I and applicable stakeholders.
- Perform additional duties as assigned.
Training Administration and Compliance
- Monitor training completion rates, identify at-risk or past-due training items, and proactively escalate concerns, as applicable.
- Assist in developing and updating training materials, including slide decks, assessments, and Read-and-Understand documents for GxP and SOP-based training programs.
- Support new hire orientation and classroom training activities.
- Compile and organize training completion data and generate routine compliance reports for review by management.
- Maintain training records in an organized, accurate, and audit-ready state.
- Perform additional duties as assigned.
Requirements- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
- Minimum of 5 years of 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 multi-task and prioritize work with minimal supervision.
- Excellent interpersonal, verbal, and written communication skills.
- Strong organizational skills with the 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.
Wisconsin pay range
$78,000-$98,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
