In this role, you will be responsible for preparing, reviewing, and maintaining essential documentation such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) manuals. You will create and edit procedure manuals, quality control manuals, engineering documents, manufacturing instructions, and change authorizations in compliance with company policies and government regulations. Additionally, you will implement and manage documentation systems, propose change control processes, and coordinate the review and approval of procedures and forms. You will provide input on quality control procedures and R&D documentation, and act as an advisor to colleagues due to your extensive knowledge and skills. You will identify innovative solutions to problems, taking a broader perspective that benefits the organization, and foster collaboration and communication within the team and across groups. You will train and guide team members, helping achieve the goal of delivering the best healthcare to patients, and manage your own time and professional development while allocating tasks to others. You will act as the go-to person for key areas of administrative expertise and execution, and route various documents through the Document Management System (DMS) for necessary reviews and approvals. You will process documentation for effective dating as directed by your supervisor, and handle the creation, distribution, retrieval, and storage of production logbooks. You will maintain the filing system within the Documentation department, review and approve documents in the change control system, and initiate and facilitate change requests in the Global Quality Tracking System (QTS). You will adhere to all plant safety rules, follow standard operating procedures (SOPs) and training course plans (TCPs), and ensure you stay current with all training requirements.
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Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED