(Archived) Quality Assurance Document Management Specialist III

Description

Act as a Document Management Specialist for SOPs and other GxP controlled documents generated by the Development organization. Independently and proactively identify, interpret and support document management needs that fulfill compliance and business requirements. Provide guidance and expertise to colleagues on document management processes and systems. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Initiates and completes routine and non-routine information requests in an independent and efficient manner; Makes judgments and recommendations to clients. Troubleshoots effectively and solves problems independently.
• Manages document workflows, working with authors cross-functionally to ensure that SOPs and other documents are completed on time. Plan for and coordinate release and distribution of documents.
• Keeps well informed of current information management or document management practices and systems. This includes but is not limited to the administration of, and data entry responsibilities associated with, any computerized system used to accomplish these goals. Attends training, technical or user group meetings and reports relevant information. Performs role of key user for the current electronic document management system.
• Educates end-users on information tools and their use. Routinely meets with user community to identify problems areas in the existing processes and determine solutions. Collaborates in a customer service role. Promotes use of tools and and technical writing practices to improve documents.
• Proposes new information delivery solutions based on client needs as well as overall understanding of drug development process. May provide input to hardware or software purchases.
• Works within the immediate discipline, a multi-disciplinary environment and an international environment.
• Reports and treats data with a high level of integrity and ethics. Ensures systems are operating in a validated state participating in validation and change control activities as needed.
• Complies with FDA, EPA, and OSHA regulations, performing all work in a compliant manner; Maintains proper records in accordance with SOPs and policies. Participates in and contributes to inspection readiness activities.
• Acts as a representative on committees overseeing the content of policies/procedures, as assigned (author, review, approve and circulate policies and procedures to the user community.)
• Supports and embraces diversity as an employee and representative of the company.
• Represents group in absence of supervisor; teaches others in area of expertise.

Requirements

• Master´s Degree with 3+ years experience in related information research discipline or Bachelor´s Degree with 7+ years or equivalent experience in related field
• Demonstrates knowledge of field
• Supplemental courses in area of expertise
• Ability to learn new technology and concepts and evaluate, implement and validate new electronic tools
• Demonstrating the ability to use BI Information Management/Document management systems (Veeva Vault Quality, TrackWise, LOS, Archival Systems)
• Propose new experimental designs in using electronic tools
• Independent problem detection and works with supervisor to devise strategies for solving problems
• Proven problem solving ability
• Demonstrating the ability to write standard documents
• Demonstrating the ability to write non-standard documents and create new templates and procedures
• Excellent written and verbal communication skills and proficiency in Microsoft Office 365 tools
• Good organizational skills resulting in the ability to be self-directed and manage multiple projects
• Appropriate level of understanding of applicable regulations
• Able to act for supervisor in his/her absence

Compensation Data

This position offers a base salary typically between $102,000 and $175,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.  For an overview of our benefits please click here.