St. Joseph, MO, 64501, USA
5 days ago
Associate III, Quality Systems
**Description** This position has responsibility for key QA functions and the responsibility of training others to perform functions including but not limited to the coordination of documentation systems to ensure compliance, control, accountability, traceability, communication, retrieval and archiving of critical documentation throughout the lifecycle of the documents, including routing and issuance, also to ensure that all documents are appropriately filed and indexed to provide accessibility to all operating units and as necessary for Government inspections, assignment of training through Compliance wire and insuring that training is completed prior to issuance, maintenance of databases of various QA functions (document status, archived documents), and to provide timely customer service to all departments.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 workflows upon receipt of revision requests for all controlled document types (i.e. SOPs, forms, Quality Standards). + Issuance of revised documents including archival of superseded documents + Initiates Periodic Review workflows for controlled document types (SOPs, forms, quality standards) + Write, review and update SOPs related to document control procedures + Train new employees in the Document Control area + Upload quizzes into the LOS training system for new/updated procedures + Manage and file all controlled GMP documentation in compliance with internal procedures and polices as well as regulatory requirements + Establishes and is accountable for maintaining the archival, retrieval, retention and destruction of controlled documentation + Customer service functions with technical programs + Address issues with training systems as needed + Fulfill document requests that are received from various departments + Assist with preparing aseptic fill records and associated sampling documents/labels, packaging records, solution records, and other production records per the production schedule(s) + Provide second check verification of records prior to issuance to production as required + Assist with training of new employees on issuance of records **Requirements** + Minimum of high school education with five (5) years´ experience using Veeva Vault and organizational skills. + Good attention to detail. + Experience to include documentation systems and Quality assurance requirements. + Strong understanding of document filing systems. + This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications. + Must have Document Coordinator certification for use of IDEA for CON. + Knowledge of LOS software to be able to enter quizzes in the training system. + NOTE: Relevant BIAH experience may be weighted more significantly. **Desired Skills, Experience and Abilities** All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Por favor confirme su dirección de correo electrónico: Send Email