Job Description

Job Description

Job Title: Technical Writer I

Location: San Diego, CA

Work Schedule: Hybrid preferred (3 days onsite / 2 remote)

Business Hours: 8 AM – 5 PM

Industry Experience: 1–2 years in medical device or pharmaceutical field ideal

Summary of Duties and Responsibilities

• Create and edit Manufacturing Instructions and SOPs per SME instructions
• Assemble Change Control packages for review and manage associated workflows through their review and approval processes
• Contribute to work instructions, area guidelines, knowledge base topics, style guides/templates, and department SOPs
• Attend project and/or core team meetings as required
• Support the revision of existing documentation by working with stakeholders, partners, or distributors to facilitate revision, review, and approval
• Support the coordination of the collaborative review process, establish review and edit cycles
• Coordinate the transition of documentation through development, pilot, and production phases as appropriate
• Through Technical Training, maintain experience and knowledge of manufacturing processes, assays, instrumentation, and software as it applies to documentation
• Support one or two documentation projects at a time
• Prioritize deliverables and manage expedites

Required Skills

• Proficient in Microsoft Office suite
• Ability to work independently
• Good communication skills
• Background in science preferred

Skillset Matrix Manager Notes

Technology Requirements

• MS Word Suite experience required
• Agile software (or other Electronic Data Management System) desired

Typical Daily Tasks

• Editing documents (Manufacturing Instructions and SOPs)
• Working in Agile to create and manage change orders
• Interfacing with document stakeholders
• Interdepartmental collaboration for change orders

Preferred Background / Prior Work Experience

• Biology/Chemistry background desired
• Technical Writing background desired

Priority Soft Skills

• Ability to apply critical thinking to their writing
• Good communication skills (via email, Teams IM, etc.)
• Ability to work independently
• Comfortable handling multiple projects simultaneously

Thanks!

Ritika Aithmian

Lead Recruiter

Ritika.aithmian@mastechdigital.com

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