Quality Systems Specialist - EDMS
About The Position
Purpose and Scope The Quality Systems Specialist-EDMS ensures and maintains the quality system processes, including but not limited to administration and use of the Quality Management System (QMS), Electronic Document Management System (EDMS), and Electronic Learning Management System (ELMS). This position will serve as a quality representative for Veeva electronic system implementation and updates, document change controls, coordination of department documents and deviation trending. This position drives the continuous education, implementation and improvement of Quality Systems and compliance with regulations and ensures that the site's Document Processes and structure meet all business and regulatory requirements. Furthermore, this position provides guidance and assistance to ensure compliance of process procedures with applicable regulations and standards, such as, good documentation practices, quality system regulations, and organization of international standards including administrative support to the Quality organization. Essential Duties & Responsibilities Carry out responsibilities in accordance with the organization’s policies, procedures, and pharmaceutical/device regulations EDMS Administration: Administer document management systems (e.g. Veeva), maintaining databases, controlling access rights, and ensuring data integrity. Manage user access, workflows, and system configuration in Electronic Document Management Systems (EDMS). Document Control: Create, edit, and organize digital documents, including user guides, manuals, and policies, tracking all revisions. Document Lifecycle Management: Handle creation, review, approval, distribution, archiving, and destruction of controlled documents to ensure they are current. Compliance & Audit Support: Ensure all records comply with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP). Change Control: Process, track, and trend Change Requests (CRs) for document revisions. Compliance & Auditing: Ensure all documentation adheres to regulatory standards and internal policies. Logbook/Record Control: Issue, review, and reconcile production/QC logbooks and Batch Records. Process Improvement: Identify and implement digital workflows, workflows for approvals, and optimize document storage. Participate in quality system improvement initiatives including, but not limited to, ownership and support of quality systems projects (including EDMS), and other system-related tasks as required.⯠Support & Training: Train staff on using the document management system, troubleshooting, and answering inquiries regarding document retrieval. Act as a subject matter expert (SME), training teams on electronic document management systems and promoting a culture of quality. Digital Transformation: Convert paper-based records to electronic formats through scanning and indexing. Support internal, regulatory, marketing partner audits and inspections, corrective action response, and support inspection readiness activities, as requested.⯠Partner effectively with Functional Area Leaders to manage and/or lead EDMS/documentation archival related projects aligning with organizational goals and to reduce risk. Assist in the development of Quality Metrics to achieve company's Quality goals. Reports Deviation and CAPA Quality Management Review results, as needed. Monitor quality metrics, report on performance, and provide insights for continuous improvement initiatives. Troubleshoot/support Tolmar personnel with questions/issues. Perform other duties as assigned.
Requirements
- Strong familiarity with Quality Management Systems (QMS), Electronic Document Management System (EDMS), Electronic Learning Management System (ELMS), and records management in a cGMP setting.
- Knowledge of QA principles, concepts, IT/systems, data analysis tools, and industry best practices and standards.
- Working knowledge in drug or device relevant standards, and ability to function in a controlled manner regulated by FDA cGMPs & ISO standards and handle confidential data.
- Technical Proficiency: Strong knowledge of Electronic Document Management Systems (e.g., MasterControl, Veeva, SharePoint) content management software, and Microsoft Office Suite.
- Attention to Detail: Excellent proofreading, editing, and analytical skills to ensure document accuracy.
- Communication: Ability to collaborate with diverse departments and subject matter experts.
- Excellent record-keeping, attention to detail, and organizational skills.
- Ability to organize and prioritize multiple assignments
- Excellent skills in spelling, grammar, punctuation, sentence structure and proofreading
- Strong initiative required; ability to work independently with minimal direct supervision
- Strong communication (verbal and written), cross-func tional and interpersonal collaboration , problem solving and analytical skills.
- Ability to develop and/or enhance quality system processes while ensuring compliance to applicable regulatory standards.
- Ability to accurately perform detail-oriented work.
- Ability to maintain accuracy, consistency and quality of documentation and projects.
- Results-driven, with a focus on compliance.
- Ability to follow and demonstrate strong initiative and follow-through.
- Comfortable in a fast-paced and dynamic work environment.
- Bachelor’s degree in scientific discipline required.
- Knowledge of FDA, ICH, and ISO regulatory requirements specific to document control and training.
- Four (4) or more years of experience in Quality and/or Compliance in the pharmaceutical or medical device industry.
- Two (2) or more years of experience managing workflows within electronic quality systems such as TrackWise, Master Control, Veeva, Compliance Wire, Success Factors, ZenQMS, or Documentum.
- One (1) or more years of experience managing the elements of documentation systems.
Nice To Haves
- Six Sigma, LEAN certifications such as Yellow or Greenbelt, or other relevant quality certifications preferred.
Responsibilities
- Administer document management systems (e.g. Veeva), maintaining databases, controlling access rights, and ensuring data integrity.
- Manage user access, workflows, and system configuration in Electronic Document Management Systems (EDMS).
- Create, edit, and organize digital documents, including user guides, manuals, and policies, tracking all revisions.
- Handle creation, review, approval, distribution, archiving, and destruction of controlled documents to ensure they are current.
- Ensure all records comply with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
- Process, track, and trend Change Requests (CRs) for document revisions.
- Ensure all documentation adheres to regulatory standards and internal policies.
- Issue, review, and reconcile production/QC logbooks and Batch Records.
- Identify and implement digital workflows, workflows for approvals, and optimize document storage.
- Participate in quality system improvement initiatives including, but not limited to, ownership and support of quality systems projects (including EDMS), and other system-related tasks as required.
- Train staff on using the document management system, troubleshooting, and answering inquiries regarding document retrieval.
- Act as a subject matter expert (SME), training teams on electronic document management systems and promoting a culture of quality.
- Convert paper-based records to electronic formats through scanning and indexing.
- Support internal, regulatory, marketing partner audits and inspections, corrective action response, and support inspection readiness activities, as requested.
- Partner effectively with Functional Area Leaders to manage and/or lead EDMS/documentation archival related projects aligning with organizational goals and to reduce risk.
- Assist in the development of Quality Metrics to achieve company's Quality goals.
- Reports Deviation and CAPA Quality Management Review results, as needed.
- Monitor quality metrics, report on performance, and provide insights for continuous improvement initiatives.
- Troubleshoot/support Tolmar personnel with questions/issues.
- Perform other duties as assigned.
Benefits
- Benefits information: https://www.tolmar.com/careers/employee-benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
