Quality System Document Issuance Associate
It is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
Responsibilities (include but are not limited to):
The Quality Systems Document Issuance Associate will use companies Electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels .
Additional job duties include:
- Issue effective documents including procedures, test methods, specifications and batch documentation.; including final product labels.
- Issue logbooks.
- Ensure accuracy and completeness of QA issued documents.
- Support investigation of deviations against the document management system
- Perform other duties as required to fulfil department and business needs.
- Role requires shift availability during weekends.
- 1+ years of relevant experience in a GMP environment related field and MBO/HBO
- Experience in pharmaceutical industry, cell therapy, biologics, blood/human tissue, or vaccines.
- Good interpersonal, verbal and written communication skills.
- Knowledge of electronic documentation systems, data retrieval, and electronic file formats.
- Proficient with computers and word processing software (i.e. Microsoft Office products).
Because you will work with blood that requires a vaccination against hepatitis B. Either you have already been vaccinated, or are willing to get vaccinated.
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