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QMS Document Control & Training Specialist
Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.
The QMS Documentation and Training Specialist will support tasks related to employee training, documentation, and reporting. Reporting to the Training Manager under Global Quality Systems, this role will be responsible for the effective processing and review, release, and maintenance of documentation within the Document and Learning Management Systems.
What you'll be doing
- Contributes to the daily administration and coordination of training functions and events.
- Ensures 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.
- Conducts quality reviews and audits of documents to identify errors, inconsistencies, and non-compliance issues, and recommends corrective actions and improvements to enhance training & document quality and integrity.
- Collaborates with cross-functional teams, including subject matter experts (SMEs), project managers, quality assurance professionals, and regulatory affairs specialists, to gather information, review documents, and facilitate document approvals and revisions.
- Provides training and support to employees on documentation processes, systems, and tools.
- Establishes document retrieval systems and procedures to facilitate easy access, retrieval, and distribution of documents, ensuring that authorized personnel can locate and retrieve documents quickly and efficiently as needed.
- Identifies opportunities for process improvements, automation, and efficiency gains in documentation processes, systems, and workflows, and implement solutions to enhance productivity, accuracy, and compliance
- 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.
- Other duties as assigned.
- Associate’s degree and a minimum of 2 years relevant experience in Quality, Training, and/or Document Control Systems, OR without degree should have a minimum of 3-5 years relevant experience. Bachelor’s Degree preferred.
- 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.
