Technical Content Specialist

7 days ago

Indianapolis, Indiana, United States Astrix Full time

Job Summary

Astrix is seeking a skilled Technical Content Specialist to support projects related to procedures and protocols in the space of sterile drug manufacturing.

Key Responsibilities

  • Leverage technical writing strategies to ensure content of documentation is clear, concise, and complete, aligning with regulatory requirements and industry standards.
  • Author and revise technical documentation, including facility and equipment SOPs, batch records, specifications, and training documents, to ensure accuracy and compliance.
  • Develop and manage change controls as necessary to implement new procedures and revise documentation and SOPs to facilitate the launch of new products, ensuring seamless integration with existing processes.
  • Participate in process and equipment testing to gain a thorough understanding of systems being documented, fostering a culture of quality and excellence.
  • Complete deviations, CAPAs, change controls, document revisions, and training activities to meet quality system requirements and timelines, ensuring the highest level of quality and customer satisfaction.

Requirements

  • Bachelor's degree or equivalent work experience in a related field, such as technical writing, communications, or a scientific discipline.
  • At least 3 years of relevant experience in technical writing, documentation, or a related field, with a proven track record of success.
  • Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and stakeholders.
  • Demonstrated understanding of GMP/cGMP regulations and industry standards, with the ability to apply this knowledge in a practical setting.
  • Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment, with a focus on quality, efficiency, and customer satisfaction.

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