QA DOCUMENTATION SPECIALIST

The Company

Our client is leading the research of cancer immunotherapy and today their pipeline includes investigational therapies and next-generation technologies that have the power to transform the way cancer is treated: we are talking about cell therapy, immuno-oncology, and targeted therapies., that will revolutionize the way tumors are treated.  

Job Description
We are seeking a detail-oriented Quality Operations Documentation Specialist to join our client's team. In this role, you will be responsible for verifying and managing controlled batch documents and labels to ensure compliance with cGMP standards, supporting quality assurance processes and operational needs.

Responsibilities

- Verify controlled issued batch documents and label packages, including final product labels, to ensure accuracy and compliance with GMP requirements.
- Confirm the correctness of controlled logbooks and other documentation.
- Monitor the timely consumption of GMP materials and inform the responsible personnel when supplies are low.
- Ensure all QA-issued documents are complete and accurate.
- Identify compliance gaps within the controlled issuance process and escalate as necessary.
- Support strategic initiatives to improve and streamline document control procedures.
- Investigate deviations related to document control and develop effective corrective actions.
- Collaborate with colleagues and stakeholders across departments, providing cross-training where necessary.
- Support other related duties as assigned, working in accordance with GMP standards and deadlines.

Requirements
- Bachelor degree level education.
- At least 2 years' experience in document management within a regulated environment.
- Advanced proficiency in English communication, both written and verbal.
- Strong attention to detail and accuracy.
- Ability to prioritize tasks and meet deadlines consistently.
- Good interpersonal and communication skills with colleagues and stakeholders.
- Knowledge of GMP principles and document control processes.

Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.

 

57873