Technical Writer (ADX-204-19)

POSITION SUMMARY:

The Technical writer position is responsible for documentation of processes and specifications utilized in the PSP manufacturing department. They will work closely with Manufacturing, Quality Control/Assurance, Research & Development, and Logistics teams to translate laboratory processes into approved internal documents. They will author and revise internal documents and identify areas of improvement. 

RESPONSIBILITIES:

• Understand processes from both the perspective of the user and the quality system
• Translate the needs of the user into functional process documents while maintaining compliance with regulatory and quality requirements
• Translate and iterate on documents from R&D to an IVD (in-vitro diagnostic)/cGMP environment
• Project management of documentation revisions
• Author and revise documentation
• Assist in documentation hierarchical organization
• Work across departments to ensure needs are met and that input is incorporated in documentation, including:
  
  • Process Development
  • R&D
  • Manufacturing
  • Logistics
  • Purchasing
  • Quality Control
  • Quality Assurance
  • Regulatory
  • Assay Development

• Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
• Safeguarding the privacy and security of protected health information and European Union personal data.
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.

EXPERIENCE:

• 2+ years in an industry setting
• 1+ year of technical or scientific writing experience
• 2+ years of laboratory experience (preferred)
• Experience in cGMP and ISO9001 environments
• Must have demonstrated expertise in authoring SOPs or similar process directed documentation
• Microsoft Word and Adobe Acrobat
• Flowcharting software (preferred)

KEY ATTRIBUTES:

• Self Starter
• Driven to perform
• Self-directed: needs little explicit direction and no hand-holding
• Able to organize and prioritize a diverse set of responsibilities to ensure that focus on the success of the company is achieved
• Strong writing and communication skills
• Strong science acumen
• Ability to multitask and work within a fast-paced dynamic team environment.
• Strong interpersonal, team working, and leadership skills.
• Good problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent a recurrence.
• Experience with good manufacturing practice and good document practice.

EDUCATION:

• BS in biology, molecular biology, biochemistry or related field or,
• BS in English, writing, journalism or related field.