Specification Writer - GMP Supply Chain

Overview:

We are seeking an experienced and detail-oriented Specification Writer to support supply chain operations within a GMP-regulated environment. This role is responsible for translating complex technical and material data into clear, accurate, and compliant documentation that supports both new and existing material specifications.

The ideal candidate will work cross-functionally with Supply Chain, Quality, vendors, project teams, and clients to ensure material specifications are complete, current, and aligned with operational and regulatory requirements.

Job Responsibilities

• Develop, author, and maintain material specifications that are clear, accurate, and usable by both technical and non-technical stakeholders

• Ensure all documentation complies with GMP standards and applicable regulatory requirements

• Collaborate with Supply Chain, Quality, vendors, project teams, and clients to gather technical data and incorporate stakeholder feedback

• Track specification status, support prioritization, and ensure documentation readiness for operational timelines

• Support escalation, documentation, and action planning when specification approvals do not align with manufacturing or supply needs

• Establish and maintain documentation standards to ensure consistency across technical materials

• Continuously update documentation to reflect process improvements, regulatory changes, and new requirements

• Create supporting materials such as user guides and training documentation for onboarding and ongoing education

Job Qualifications:

• Bachelor’s degree in Supply Chain Management, Business, Biology, or a related field

• Experience in a Specification Writer or Technical Writer role within a GMP environment

• Experience with material management and/or material specifications

Preferred Qualifications

• Experience supporting supply chain operations within the pharmaceutical industry

• Strong organizational skills with exceptional attention to detail

• Ability to communicate complex technical information clearly to diverse audiences

• Proven ability to manage multiple projects and deadlines simultaneously

• Experience leading or coordinating documentation efforts, including tracking status, action items, and ownership