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On behalf of our client a pharmaceutical company focused on the development of medical devices for the life science industry. We are seeking an Entry-Level Documentation Specialist to join their team in Irvine, CA. As a Documentation Specialist, you will play a vital role in ensuring the smooth operation of our manufacturing processes by meticulously creating, processing, and reviewing production batch records in accordance with established GDP/GMP procedures.

Duties:

• Review documents for format, accuracy, and compliance with established procedures, collaborating with subject matter experts to provide feedback on content.
• Efficiently process Change requests in alignment with ISO/quality/change management standards by coordinating with team members.
• Execute production tasks following prescribed procedures and work instructions.
• Perform inventory and quality transactions in the SAP Inventory System.
• Complete required documentation accurately and promptly, adhering to Good Documentation Practices (GDP).

Education and Experience

• Bachelor’s degree in science, or an Associate’s degree or equivalent (preferably in a science field).
• 1-2 years of experience in a regulated industry (experience in medical device, pharmaceutical, or biotechnology sectors preferred).
• Familiarity with ERP systems such as SAP and Product Lifecycle Management is advantageous.
• Basic understanding of Good Documentation Practices (GDP) is a plus.