Capital Associated Industries, Inc.
  • Durham, NC, USA
  • Full Time

CoImmune Inc. is a US company based in Durham North Carolina that was founded in 2019 based on its expertise in the development and manufacture of cell-based therapeutics to treat unmet medical needs including cancer, autoimmune and inflammatory diseases. CoImmune has a 20,000 sq. ft. cGMP manufacturing facility capable of supporting clinical studies from Phase I through Phase 3. The company is preparing to initiate its first Phase 2 clinical trial using a strategic combination of immune-oncology therapeutics. In addition to developing its own therapeutic pipeline, the company plans to use its excess cGMP manufacturing capacity to provide revenue-generating contract services for the manufacturing of third-party clinical stage cell-based products.    

SCOPE:                

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

RESPONSIBILITIES:

  • 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.

QUALIFICATIONS:

  • 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%)

 

Capital Associated Industries, Inc.
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