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INCOG BioPharma Services · 1 month ago

Supply Chain Specification Writer

Fishers, IN

Full-time

Onsite

Entry, Mid Level

2+ years exp

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, ensuring that all materials meet regulatory and quality standards.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

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

Qualification

GMP complianceMaterial specificationsTechnical writingSupply chain managementProject managementOrganizational skillsCollaborationAttention to detail

Required

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

Preferred

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

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees