General Description of cGMP QA/QC Document Specialist:
Assist in the creation of Standard Operating Procedures and related cGMP Documentation. P erform daily tasks and complete routine department procedures under the direction of the Director of Quality Assurance.
Tasks include but not limited to the following:
- Creating Manufacturing Documents from customer formulations
- Creating SOP’s for product manufacturing.
- Assisting in the conceptualization and implementation of next generation document creation system.
- Supporting document creation/change system.
- Other QA related tasks as applicable.
- Assist in the Management of training system documents, CAPA and change control processes.
Knowledge, Skills and Abilities Required:
- Knowledge of cGMP is required.
- Sufficient Science background and understanding to write technical documents.
- Associates degree as a minimum; Bachelor's degree in Chemistry, Biochemistry, or a Biological science preferred
- One year experience in industry as a minimum.
- Office and Laboratory work experience preferred