Supply Chain Specification Writer
Description
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. The Specification Writer will work closely with Supply Chain, External Vendors, Clients and other cross-functional teams to create comprehensive documentation that supports new material specifications and updates for existing specifications, ensuring that all materials meet regulatory and quality standards.
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:
- Education: College Degree or Equivalent experience demonstrated in this field
- Experience: 2-4 years previous experience in a Specification / Technical Writer role (pharma preferred).
Additional Preferences:
- Strong understanding of GMP manufacturing processes and regulatory requirements.
- 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.
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.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.