Document Specialist

As a Document Specialist, you will serve as the principal point of contact for coordination with functional leaders and subject matter experts on document creation and prioritization. You will author, edit, and maintain technical documents, including batch records and change controls. Your role will involve coordinating documentation activities for large initiatives, planning, organizing, and tracking multiple document deliverables. You will translate scientific and operational concepts into clear and compliant documentation tailored to intended audiences, leading coordination of document reviews and approvals across multiple functions.

Ensuring the on-time and high-quality delivery of documentation is a key part of this role, as well as using software tools to develop high-quality documents.

• Serve as the principal point of contact for coordination with functional leaders and subject matter experts on document creation and prioritization.
• Author, edit, and maintain technical documents including batch records and change controls.
• Coordinate documentation activities for large initiatives, including planning, organizing, and tracking multiple document deliverables.
• Translate scientific and operational concepts into clear and compliant documentation tailored to intended audiences.
• Lead coordination of document reviews and approvals across multiple functions.
• Ensure on-time and high-quality delivery of documentation.
• Use software tools such as Word, Excel, structured authoring tools, and document management systems to develop high-quality documents.
• Review incoming document change requests and author control documents.

• 1+ years of experience in the pharmaceutical, biotech, or GMP manufacturing industry.
• Experience authoring and editing controlled documentation such as batch records, SOPs, work instructions, and change controls.
• Technical writing experience in a regulated environment.
• Experience working cross-functionally with SMEs and operational teams.
• Strong document review, proofreading, and version control skills.
• Experience with document management systems such as Veeva, Master Control, Documentum, Track Wise, Open Text.
• Ability to work independently with minimal supervision while taking direction for non-routine or complex assignments.

• Bachelor's degree in Technical Writing, English, Communications, Science, Engineering, or a related field.
• Highly organized with strong attention to detail.
• Self-starter capable of working independently.
• Strong interpersonal and communication skills.
• Not afraid to ask questions or seek guidance.
• Adaptable to new processes and sudden changes in workflow.
• Comfortable managing multiple priorities.
• Strong problem-solving and troubleshooting abilities.

This position is onsite in Foster City, CA. The company offers a comprehensive time-off package, including 10 days of PTO and 13 paid holidays annually, supporting work-life balance. You will serve as a key operational partner to the Process Development organization, with broad ownership of electronic batch record management, collaborating with Chemistry, Quality Assurance, and Manufacturing.

This is a Contract position based out of Foster City, CA.

The pay range for this position is $36.05 - $38.46/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are…