QA Specialist

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Pleasanton, CA.

Our client is a rapidly expanding clinical-stage biotech developing targeted immunotherapies for both cancer and infectious disease. Their approach is to generate therapeutic immune response through leveraging insights into our immune system's ability to identify and remove diseased cells by targeting specific antigens. They believe that activating and directing the immune system to such targets could lead to significant progress in the delivering the advantages of immunotherapy to a greater number of patients.

Job Responsibilities:

• Responsible for maintaining document control and document archive functions, and for facilitating processes for change control, training systems, vendor management, metrics reporting, and CAPA systems.
• Supports the drug product manufacturing process with the following responsibilities:
• Maintain a GMP compliant document control function facilitating appropriate processes, procedures, and practices.
• Facilitate the process of creating, reviewing, approving and archiving standard operating procedures (SOPs), Batch Records, Work Instructions, etc.

Skills and Requirements:

• BA/BS required if no previous experience in Document Management
• 1+ years of experience in document management in a regulated industry
• Master Control Document Management System experience is a plus

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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