Quality Assurance Specialist
3 weeks ago
Quality Assurance Specialist (Pharmaceutical)
Location: Irvine, CA
Hours: 7:00 AM - 3:30 PM, Onsite
Pay Rate: $27/hr.
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.
- Printing batch records, filling SOP’s and CAPA’s
- 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 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).
- Must have experience on printing batch records, filling SOP’s, NCRs, and CAPA’s
- Familiarity with ERP systems such as SAP and Product Lifecycle Management is advantageous.
- Basic understanding of Good Documentation Practices (GDP) is a plus.
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