Document Control Specialist
Location
Portage, IN | United States
Job description
Title: Document Control Specialist
Location: Portage, IN
Type: Contract
Start: ASAP
Overview: 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.
Responsibilities: - Overall coordination of controlled documentation within the company
- Performs the Document Control function within the Mastercontrol system: Facilitates and maintains the flow of documents and training tasks through MasterControl
- 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 MasterControl
- 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 MasterControl end user issues and requests
- Acts as Single Point of Contact for all controlled document requests
- Creates, tracks and trends data from FBS 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 of MasterControl
- Manages and maintains paper and electronic training files
- Creates and maintains MasterControl reports
- Manages Periodic Reviews and Revisions of documents in MasterControl
- 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 all 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 with various levels of management
- Works independently on and successfully solves problems to complete/qualify identified systems and tasks within given constraint of scope, time and schedule.
Requirements: - HS degree required/ AS degree or college coursework preferred
- Minimum 5-year of administrative assistant experience in a regulated environment 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
- Document Management and Training Specialist
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