Harba Solutions Limited
Specification Writer - GMP Supply Chain
Harba Solutions Limited, Indianapolis, Indiana, us, 46262
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
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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
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