Compensation DataThe base salary range for this position is $75,000.00 to $122,000.00 USD. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. 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.
DescriptionThe 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. The incumbent will provide guidance to colleagues on the processes and systems for document management and archiving as well as identify, interpret, and define document management needs and improvements that fulfill compliance and business requirements.
Duties & 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.
- Support and maintain 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.
- Monitor and triage the training mailbox, providing customer support for questions and escalations when needed.
Requirements- 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.
Desired Skills, Experience and Abilities- Experience working with a Learning Management System (LMS) (e.g., SuccessFactors, Cornerstone, SumTotal, etc.)
- Experience working with an electronic Document Management System (eDMS) (e.g. Veeva Vault Quality)
