9 month contract (Great potential to extend or convert)
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.
Please submit your resume in a Word or PDF format to be considered.