Alphanumeric is hiring a TECHNICAL AUTHOR to work in St. Louis, MO with one of the largest pharmaceutical companies in the world.
- Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
- Comply with and support the Environmental, Health and Safety policies and procedures.
- Create User Requirement Specifications in accordance with Site SOP’s and cGMP’s.
- Create and Update of Standard Operation Procedures in consultation with Subject Matter Experts
- Create and update batch records and department forms
- Stream-line batch documentation and Standard Operation Procedures within the Manufacturing department using lean methodologies.
- Participate in Root Cause Analysis and creation of Corrective and Preventative Actions, particularly as it relates to batch documentation and SOP’s.
- Comply with all operational safety, process safety, environmental permits, Quality policies, procedures and training requirements.
- 2 years related experience with High School Diploma or 0 years with Bachelor’s Degree
- Competent in use of templates and forms
- Strong skills in Microsoft Excel, Microsoft Office, and Powerpoint
- Good understanding of GMP documentation practices
- Ability to understand technical processes and communicate those to others
- Ability to train/coach others without use of authority
- Strong command of the English language, including proper use of spelling, grammar, and typical technical writing standards.