Quality Document Management Specialist II

About the role

The Quality Document Management Specialist II will act as a Document Management Specialist for SOPs, other GxP documents, and archived records generated by the Development organization. This role will conduct activities supporting document management and archiving operations.

Responsibilities

• Contributes to the management of the on-site archive.
• Accountable for the receipt, indexing, storage, retention, and retrieval of records submitted to the archive.
• Responsible for conducting and refining processes that enable effective preservation, access to, and security of digital and paper archives.
• Identifies and proposes process improvements.
• Provides controlled document support by managing the document life cycle in the electronic Document Management System (eDMS).
• Manages workflows, facilitates the use of appropriate document types and technical formats.
• Executes the periodic review process.
• Collaborates with document owners and cross-functional teams to ensure quality standards are met.
• Regularly communicates with internal customers to keep them informed.
• Provides expertise in records management and preservation of electronic records.
• Participates in working groups and task forces related to electronic records and digital information.
• Automates and improves processes using AI/digital tools.
• Serves as a Subject Matter Expert (SME) on eDMS, advises document owners on good documentation practices and Boehringer Ingelheim standards, and executes various document management service components.
• Provides end user training on document management processes and systems.
• Contributes to proposals for enhancements and testing to implement additional functionality within eDMS.
• Participates in and contribute to inspection readiness activities.
• Acts as a point of contact for audit questions related to the archive and document management during internal, corporate, and regulatory authority inspections.
• Resolves straight forward observations noted during audits/inspections.
• Supports and maintains training assignments and documentation within the Learning Management System (LMS) to ensure accurate and timely capture of training events and records.
• Create and maintain training curriculums/roles within the Learning Management System including providing quality checks and assisting with KPI generation.
• Maintain the training mailbox, providing customer support for questions and escalations when needed.

Qualifications

• Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
• Bachelor’s degree from an accredited institution with three-plus (3+) years or equivalent experience in related field.
• Demonstrates knowledge of document lifecycle management and archiving processes and systems including regulatory and compliance requirements.
• Previous experience in pharmaceutical industry and knowledge of GLP/GMP regulations is a plus.
• Proficiency in Microsoft Office 365 tools and knowledge of other tools (e.g. Power Apps etc.).
• Requires minimal supervision in applying new technology and concepts and evaluating and implementing new electronic tools.
• Demonstrates ability to detect problems and define solutions.
• High degree of attention to detail.
• Ability to find errors or inconsistencies that others may miss.
• Demonstrates the ability to write standard documents.
• Excellent written and verbal communication skills.
• Ability to communicate outside of Development to Legal, IT and other functions.
• Excellent conflict resolution and negotiation skills.
• Strong organizational skills resulting in the ability to be self-directed and manage multiple tasks.

Benefits

Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here.