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.
- 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
- Quality Control
- Quality Assurance
- 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.
- 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)
- 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.
- BS in biology, molecular biology, biochemistry or related field or,
- BS in English, writing, journalism or related field.
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