QA/QC Document Specialist
Lab Support - Hollister, CA

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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.
Other Qualifications:
  • 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

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