What are the responsibilities and job description for the Quality Control / Documentation Analyst position at Katalyst Healthcares & Life Sciences?
Job Description:
- Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team.
- This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
- In this role, the primary responsibility for the individual in this position is to assist in instrument/method projects with some supervision. The projects may require attending meetings based on the specific project, document writing/revising to ensure compliance with regulations and quality control practices.
- The person in this role may also be asked to revise documents to assist in the daily operations of the team.
Responsibilities:
- 75% Executing experiments and procedures as detailed by lab manager and staff.
- 25% Writing /revising documents procedures and validation documentation.
Education and Experience Requirements:
- Essential: Minimum Bachelor's degree in Chemistry/Biology/Biochemistry.
- Desired: Experience in a laboratory environment is preferred.
- Experience with Matlab or other chemometric software.