Documentation Specialist

1 week ago


Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

Documentation Specialist

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.
  • 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.


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