POSITION SUMMARY:
The Technical writer position is responsible for documentation of processes and specifications utilized in the Operations department. They will work closely with Manufacturing, Quality Control/Assurance, Research & Development, Engineering and Logistics teams to translate processes into approved internal documents. They will author and revise internal documents and identify areas of improvement. In addition, this role is responsible for the scheduling and resource management of incoming and ongoing projects for the technical writing team. This position supervises part-time and contractor level employees.
RESPONSIBILITIES:
Job performance will involve a variety of activities including:

• 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 manufacturing, quality control/assurance, R&D, engineering and logistics departments 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
  • Engineering
• Maintain global tracking of documents within the technical writing team.
• Assess new requests for level of effort and time/resource allocation.
• Assign projects/tasks out to technical writing team for timely completion.
• Point of contact cross-functionally for status of documentation projects.
• Supervise contract and part-time technical writers.
• Create and execute training and onboarding of new technical writing staff.
• Track to and adhere to regulations, standards and guidances that govern the processes documented within the Operations department umbrella (e.g., 21 CFR 820, ISO13485, etc.)
• 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 managing multiple projects, resources, and/or teams.
• 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.