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Job: Specialist Document Management and Control, CoImmune Inc., Durham, NC

General Information

Job title:
Specialist Document Management and Control
Job location:
Durham, NC  27704 United States
Requisition code:
Date posted:
Job category:
Documentation & Technical Writing
Employment type:
Full time

Job Description

Carry out the activities of the Document Management and Control Department, which maintains GxP documents and develops and implements document management processes.

• Perform daily activities of Document Management and Control department
• Author, edit, and approve document management and quality assurance procedures (e.g., SOPs, Master Production
Records, Test Methods, Stability and Validation Protocols and Reports, and Item Specifications), as per governing
document formatting SOPs
• Maintain Master Production records, electronically and as hardcopy
• Perform non-technical review of documents, as needed
• Process temporary change requests in Master Control
• Respond to internal customer requests (i.e., document information copies), as needed
• Scan and file hardcopy documents, as needed
• Upload documents into electronic documentation system
• Issue Batch Production Records and/or labels for study kits, study medication shipments, and /or final product labels, and
reconcile returned labels, as needed
• Maintain master lists of documents, as needed
• Provide technical and compliance expertise concerning document management to all areas of the company.
• Plan, develop, implement, and enforce document management policies for the company to support research, regulatory
submissions, and manufacturing activities for multiple projects
• Oversee the periodic review of approved documents to ensure compliance with internal procedures
• Work with QA to implement quality management systems in Master Control
• Archive hardcopy documents for off-site storage
• Build solid cross-functional relationships.
• Participate in internal and external audits, as needed to support Quality Assurance
• Participate in Annual Product Reviews
• Provide support to Quality Assurance, as needed
• Perform other related activities as required.

Job Requirements

• Bachelor’s degree with 5+ years related experience in pharmaceutical/biopharmaceutical industry, which includes
document management and training experience, or equivalent combination of education and experience
• Experience with electronic document control systems (Master Control preferred)
• Demonstrated strong communication skills, both written and verbal
• Proficiency in creating and editing procedural documents, specifically SOPs, Test Methods, and Validation Documents
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Ability to respond professionally to common and/or sensitive inquiries or complaints from internal/external customers or
regulatory agencies
• Knowledge of regulations governing documentation and training programs
• Strong, effective organizational skills required; detail oriented; ability to multi-task
• Must be able to successfully work across functional areas and interface with area management
• Computer literate with experience in Microsoft Office, SharePoint, Visio, and Adobe Acrobat
• Proficient grammar skills which reflect a strong aptitude for reviewing documents from a grammatical perspective
• Ability and willingness to be regularly, predictably and reliably at work
• Ability to travel for external audits if needed (< 5%)
(Job number: 3847945)
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