Sr. Document Control Specialist

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

The parallel development of custom software solutions commensurate with the groundbreaking nature of this discovery platform, to enable the collection, analysis, and understanding of the large, high-content datasets that these microscopes produce, is key to Eikon’s mission of discovering new life-saving drugs.

Position

Eikon is looking for an experienced document control specialist that will work with diverse teams to define, set up, and manage a document control system.  Documents that need to be managed include critical engineering requirements and designs, SOPs and BOMs.  You will work closely with engineers to process documents related to product improvements, changes, and new product development.

What You’ll Do

• Store, manage and track company documents
• Lead effort to establish Eikon’s document lifecycle procedures:
  • BOM and document structure
  • Sign-off lists
  • Part numbering schemes
  • Document lifecycle (draft, release, revision)
• Responsible for setting up and reviewing Items / BOMs and their settings, electronically filing drawings, specifications, assembly instructions and miscellaneous engineering and product related documents
• Responsible for setting up and reviewing SOPs, program test plans and validation reports
• Work with program management to document approvals for key program milestones such as design reviews and validation results
• Establish and enforce document formats and styles
• Establish record retention schedule
• Manage and control the retrieval of documents
• Receive and process Requests for Information, or RFIs, from employees or clients and maintain the requests via tracking logs
• Responsible for training employees on records management procedures and policies, which include documentation, retention, retrieval, destruction, and disaster recovery
• Assist with file migrations and audits, and perform administrative tasks as needed
• Actively participate in process improvement

Qualifications

• 10+ years’ experience in document control and Quality systems
• Bachelor’s degree or equivalent experience
• Self-directed, ability to work independently and highly motivated
• Comfortable working in a fast-paced and deadline-driven environment
• Detail-oriented and dependable
• Ability to prioritize, manage time well, multitask and troubleshoot
• Strong interpersonal, communication and customer service skills
• Well versed in Microsoft Office products and SharePoint
• Experience with document control software

 Additionally, the following experience/qualifications would be a plus:

• Experience with ERP systems such as SAP
• Experience working within a Quality organization
• Biotech/manufacturing experience

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.