Specification Writer
Summary
INCOG BioPharma Services is seeking an experienced and detail-oriented Specification Writer to join our supply chain team. This role is crucial for translating complex technical data into clear, accurate, and accessible documentation.
Essential Job Functions
Develop, author, and maintain material specifications, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.
Ensure all documentation is compliant with GMP standards and meets regulatory requirements.
Work closely with Supply Chain, vendors, Quality, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest material information and stakeholder feedback.
Understand material requirements, track progress of specifications, and support prioritization to ensure operational readiness.
Support escalation, documentation, and generate action items for path forward when specification approval does not align with operational timelines or requirements.
Establish and maintain documentation standards to ensure consistency across all technical documents.
Continuously review and update documents to reflect process improvements, new requirements, and regulatory changes.
Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding material specifications.
Special Job Requirements
College Degree in supply chain management, business, biology, or related field
2+ years’ experience in a Specification / Technical Writer role within a GMP environment
Experience with material management and/or material specifications
Additional Preferences
Past experience with supply chain operations within the pharmaceutical industry
Excellent organizational skills with high attention to detail
Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences
Ability to manage multiple projects and deadlines simultaneously
Lead, manage, and facilitate an organized approach to capturing and communicating specification status, required actions, and responsible parties required to ensure timely effectiveness of specifications.
Additional Info About INCOG BioPharma Services
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.