QMS Documentation & Training Analyst

Key Responsibilities

• Contributes to the daily administration and coordination of document control & training functions and events.
• Safeguards timely assignment and release of required training for all personnel in Document and Learning Management Systems (SmartSolve & Bio Learn).
• Develops and maintains training reports for metrics and training effectiveness.
• Collaborates with key stakeholders for effective training matrix, training plans and curricula review and approval.
• Reviews, edits, and formats documents, including standard operating procedures (SOPs), forms, templates, and reports, ensuring accuracy, clarity, and compliance with established guidelines and standards prior to electronic release into the documentation and training process.
• Establishes and maintains document control processes, including version control, document tracking, distribution, and archival, and retention to ensure that documents are current, accessible, and responsibly managed throughout their lifecycle.
• Ensures that documentation practices comply with regulatory requirements, industry standards, and best practices, such as ISO standards, FDA regulations, GDPR, and other relevant regulations, by staying informed about regulatory changes and updates.
• Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.

Education And Experience (Knowledge, Skills & Abilities)

• Demonstrated ability and willingness to collaborate and partner with cross functional stakeholders.
• Learning Management System and/or Document Control experience.
• Knowledge of Quality Systems, FDA, ISO regulations and compliance.
• Knowledge of other regulations (EU-MDR, Japanese, Australian, etc.) is a plus.
• Strong verbal and written communication skills.
• Strong computer skills required, especially in Microsoft Office, especially Word and Excel, Learning Management systems, and electronic Quality Management Systems.
• Able to make presentations and conduct training.
• Good interpersonal skills; Experience interfacing with all levels of the organization, exhibiting strong communication skills; Strong commitment to teamwork.
• Able to convey needed corrective action on documentation processes to internal customers in a positive manner and facilitate agreement.
• Experience with DMS and LMS preferred; Proficient user of Microsoft Excel, using advanced functionality.