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Regulatory Compliance Writer

2 months ago

Waco, Texas, United States PSC Biotech Full time
About PSC Biotech

PSC Biotech stands at the forefront of delivering vital services to the life sciences sector, ensuring that the creation, production, and distribution of healthcare products adhere to the utmost standards and regulatory frameworks.

Our team, comprising a diverse array of professionals across North America, Europe, Asia, and the Middle East, is committed to supporting our clients in achieving their goals.

Position Summary
  • We are in search of a meticulous Documentation Specialist to become a part of our team.
  • Responsible for drafting precise and comprehensive protocols and reports related to the transfer of analytical test methodologies.
  • Engage with subject matter experts and interdisciplinary teams to guarantee the precision of documentation.
  • Develop and revise test specification documents for both raw materials and end products.
  • Compose analytical procedures and oversee technical documentation within the electronic management system.
  • Conduct comparative analyses for analytical testing and support project initiatives within the analytical laboratory.
  • Maintain up-to-date knowledge of industry regulations to ensure adherence.
Qualifications
  • A minimum of 3 years of experience in technical writing within a cGMP setting.
  • In-depth understanding of cGMP regulations and analytical methodologies.
  • Proficient in using electronic document management systems.
  • Exceptional communication abilities, keen attention to detail, and capacity to work autonomously.
  • Readiness to travel for project-related assignments.
Employee Benefits
  • Comprehensive Medical, Dental, and Vision insurance.
  • 401(k) plan with matching contributions, Paid Time Off, and Paid Holidays.
  • Support for Education and Fitness initiatives.
  • Financial incentives and discounts.