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Document Control Specialist

2 months ago

Portage, United States Ursitti Enterprises LLC Full time

Job Summary:

The Document Control Specialist coordinates and maintains the company's Document Control and Training system, strictly follows established company policies and procedures to ensure compliance with pharmaceutical industry regulations and standards, as well as maintaining record and document control, data integrity, and training associated with automated and manual/paper-based processes. The Document Control Specialist will report to the Program Manager, Training and Document Control Responsibilities:

Overall coordination of controlled documentation within the company Performs the Document Control function within the Master Control system: Facilitates and maintains the flow of documents and training tasks through Master Control. Manages document lifecycle and approval process including, but not limited to Author, revise, route, review, approve, release, and distribute documents, both in the paper and electronic systems Works with cross-functional teams to ensure documents are made effective in a timely manner. Ensures proper formatting of all controlled documents according to SOPs in both paper and electronic systems. Trains and serves as backup System Administrator for Master Control Participate in implementation of new electronic systems company-wide as it relates to training, document storage, retention, and issuance. Investigates and responds to corrective actions related to Document Control and Training Acts as primary point of contact for day-to-day Master Control end user issues and requests. Acts as Single Point of Contact for all controlled document requests. Creates, tracks and trends data from F8S and Document Control, working closely with other functions to identify, monitor, and influence process improvements. Provides support for the training function as primary point of contact for creation, revision, and deactivation of new user training, job codes, courses, training materials, and exams. Works with functional area managers to author, assign, and deliver training. Assists with New Hire Onboarding Training Trains employees on use and access at Master Control Manages and maintains paper and electronic training files. Creates and maintains Master Control reports. Manages Periodic Reviews and Revisions of documents in Master Control Manages and maintains the Document Control Center (physical record archives) including organization, filing, and retrieval of documents, as needed. Creates and maintains a record retention schedule for both paper and electronic systems per applicable regulations. Physical filing of paper records submitted for retention. Scans appropriate paper documents submitted for retention and stores electronic scanned files. Adheres to the Corporate and Company record retention policy for documents stored within the Document Control archive room, including record cleanout and destruction. Manages relationship with third-party for off-site documentation retention and requests for documents from third-party. Ensures timely distribution, retrieval, and reconciliation of required documents. Issues controlled paper documents including but not limited to Production Batch Records, Production Labels, Logbooks Assists in supporting internal and external audits, coordinating activities in backroom and ensuring timely file retrieval and response to document and training requests. Ability to manage complex programs in a dynamic environment interacting within various levels of management. Other duties within Document Control, Training, and Quality as necessary. Qualifications:

Minimum 5 years of administrative assistant experience in a regulated environment preferred. High School Diploma required, associate degree or college coursework preferred. Experience with Electronic Document Management required (Master Control is highly desirable) Excellent Microsoft Word skills, including performing complex formatting, outlining, reviewing, track changes and ability to be self-directed in performing these tasks. Strong experience with Microsoft Office Products including Word, Excel, PowerPoint, and Teams Knowledge of GxP regulations preferred. Previous experience and knowledge of GxP regulations, with the ability to author, understand and follow Standard Operating Procedures in a regulated environment is preferred. Ability to work in a cross-functional, team-oriented environment. Proactive, self-directed individual with strong organizational skills and outstanding attention to detail with the ability to prioritize, multitask and work with a high degree of accuracy and recall. Possess a positive attitude, strong interpersonal skills, and a high level of motivation. Ability to communicate effectively, both orally and in writing.

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