Job ID: 26298482
Application Type: Seeking Full-time (post graduate opportunities)
Job Title: Quality Assurance Document Specialist
Description: Position Summary: The Quality Assurance Document Specialist is responsible for supporting the quality system processes through accurate maintenance and processing of all documentation produced through the clinical manufacturing process. Essential Duties and Responsibilities: Responsible for maintaining quality assurance standards, processes and controls, and to positively model and represent those standards, processes and controls to all employees with emphasis on the following concepts and ideals: compliance with the corporate quality manual compliance with internal SOPs continual process improvement demonstration of good documentation practices Support quality assurance programs and processes by: document all incoming documents on applicable spreadsheets, and assign and distribute to auditors when appropriate maintenance of documentation in accordance with internal procedures scanning and e-filing organization and filing hardcopies archival route documents for approval proofread documents maintenance of back-up copies of current controlled document revisions develop or improve organization methods for easy retrieval of documentation assemble and label documentation packets write true copy certification statements for scanned document packets Maintain controlled documents via AssurX utilization of the content management system(s) to access data, run queries, and compile reports develop queries for effective retrieval of information from the content management system(s) upload documentation into the document management system in accordance with SOPs process document change requests and assign training to appropriate individuals Support internal audits performed by department members by retrieving records which will be audited Support the supplier evaluation program by communicating and soliciting information from suppliers as requested by Quality Assurance Specialists Participate in meetings to understand current departmental needs and project status. Take minutes (highly organized notes which maintain professional tone and identify discussion points, action items, and assigned personnel) Expected to become familiar with all of Aldevron's products and services and all associated systems, especially those systems which support the Quality Management System. Provide support during external inspections by regulatory agencies /clients or fulfil client requests as appropriate: scan MBR and other lot-specific documentation for distribution to project management/clients watermark documents to provide to clients, when requested provide evidence of effectivity of documents, when requested assist with inspection readiness activities through preparation of documents and ensuring they are presentable and appropriate for the audience perform redaction when necessary to protect client confidentiality schedule and ensure performance of facility walk-through inspections All employees are responsible for the general upkeep of work and shared spaces Other duties as assigned Qualifications: Experience: 1 year of document control experience within a field subject to regulatory compliance is preferred Education: Completion of college degree, completion of a relevant certification program, or equivalent work experience Skills and Knowledge: Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels Familiarity with Content Management Systems, preferably AssurX, NetSuite, and SharePoint Proficient with Microsoft Office Suite, including advanced Excel functions (e.g., pivot tables) Abilities: Ability to work on cross functional teams Ability to multitask, function under deadline, and provide high-quality deliverables Personal Characteristics: Demonstrate high ethical standards, trustworthiness and leadership skills Highly organized Working Conditions: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines. Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand walk bend lift up to 50 pounds use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time.
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