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Technical Project Communicator

Advantage Technical
Norton, MA Full Time
POSTED ON 5/3/2025
AVAILABLE BEFORE 5/31/2025

Manufacturing Technical Writer-SOP

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This is a long-term contract opportunity for an experienced Manufacturing Technical Procedure Writer to join the team at advantage-technical.

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The role involves drafting, revising, and maintaining SOPs, batch records, and technical documentation that meet GMP and global regulatory standards.

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You will collaborate with cross-functional teams to ensure clarity, accuracy, and compliance in all documents used on the manufacturing floor.

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Key Responsibilities:

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  • Draft, revise, and maintain SOPs, batch records, and technical documentation that meet GMP and global regulatory standards
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  • Collaborate with cross-functional teams to ensure clarity, accuracy, and compliance in all documents used on the manufacturing floor
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  • Partner with SMEs across manufacturing, quality, engineering, and validation to ensure accuracy and usability
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  • Maintain document version control using EDMS tools
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  • Contribute to audit readiness by keeping documentation up to date and inspection-ready
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  • Support training efforts by creating materials aligned with SOPs and operational needs
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  • Occasionally be in the manufacturing cleanroom or production areas
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      Requirements:

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      • Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field
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      • 5-7 years of technical writing experience for Sr. 2-4 years of technical writing experience for Jr. 2 years of technical writing experience in a pharmaceutical, biotechnology, or regulated manufacturing environment
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      • Familiarity with GMP and regulatory requirements is highly preferred
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