We are seeking candidates interested in working for an exciting start-up company located in San Francisco. This is an ideal opportunity for individuals who thrive in a changing environment and enjoy supporting and delivering world-class products that meet both external and internal customer needs.
This is a role for someone who craves a challenge balanced by the desire to be accountable for delivering high quality products for Twist. It is both a strategic and a tactical position. Those that do not want to get their hands dirty should not apply.
As a Document Control Specialist, you will be working closely with the operations and tech transfer teams. You will be responsible for establishing and maintaining a document control system for manufacturing SOP’s, Work Instructions, Batch Records, etc. The successful candidate must have a demonstrated capability to maintain a document control system in a high throughput manufacturing environment. This position requires an individual who is motivated to establish a document control system from the ground-up. A basic understanding of molecular biology and chemistry as it applies to a complex manufacturing process is required. The ideal candidate will also have previous experience writing manufacturing process documents. In this position, you will report to the Director, Product Development.
Job Duties include but are not limited to:
- Work with the Twist Atlassian specialists to create a document control server
- Post and maintain manufacturing documents under revision control
- Archive obsolete documentation
- Create a process whereby the most recent revision of work instructions is available to manufacturing operators
- Train operations personnel in the document control system
- Create a numbering system for all documents
- Create and maintain a style guide for SOP’s, Work Instructions, Batch Records, etc.
- Ensure documents conform to Twist Quality Management Systems, and/or external regulatory requirements ( GMP, GLP, ISO etc)
- Ensure that all documents are professional, neat and easily understood
- Ensure timely distribution of latest revision level documentation to all appropriate users
- Ensure that obsolete documentation is removed from distribution.
- BS in Biochemistry, Chemistry, Molecular Biology or related field
- 5+ years industrial experience maintaining a document control system
- Hands on experience with electronic document management applications within Agile, SAP, Confluence, etc
- Experience writing documents in a manufacturing environment
- Experience authoring and managing documentation through a system development lifecycle
- Strong working knowledge of Microsoft Word, Excel, PowerPoint
- Ability to thrive and multi-task in a steady-paced environment
- Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes
- Excellent communication skills including: technical writing, interpersonal and collaborative skills
- Excellent organization skills with the ability to stay accountable to deliverables and milestones
- Experience with Atlassian software products is a major plus