Job Description

Our local partner is a leader in clinical and scientific research in the biotech industry. The company takes pride in their research, behind the prevention and cure of cancer and other life-threatening diseases, guided by a patient-centered philosophy! Come join a leading organization, working towards saving lives through science!

Position Summary:

The QA Change Specialist will support clinical product and cell growth media final disposition by reviewing executed manufacturing batch records, analytical testing data, and ensuring compliance to in a manufacturing environment.

Responsibilities:

- Perform line clearances, in-process checks, label issuance, batch record issuance, monitoring of labeling activities, cell bank control and issuance, and final product control.

- Perform inspection and release of incoming GMP raw materials according to appropriate material specifications and standard operating procedures.

- Perform document change control activities.

- Write, edit, and review of controlled documents to ensure documents comply with applicable regulatory requirements.

- Prepare and maintain training and competency files.

- Write and review investigations and product complaints to determine root cause and identify/implement related CAPA.

- Ensure that all necessary quality records have been completed and reviewed/approved by responsible personnel.

- Participate in audits and regulatory inspections as assigned.

To Apply Directly : Apply with Get.It
Employment Type: Full-Time
Salary: $ 50,000.00 80,000.00 Per Year

Job Tags

Full time, Local area,

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