Document Control Specialist

4 weeks ago


San Carlos, United States Kelly Science, Engineering, Technology & Telecom Full time

Document Control Specialist

Type: 6-month temporary with possibility of extension

Shift: Monday – Friday, 8 AM – 5 PM

Onsite: San Carlos, California 94070

Pay: $25 - $30

Overview:

Kelly Science and Clinical is hiring a temporary Document Control Specialist. This role is crucial in providing day-to-day support for the development, revision, and issuance of GxP documentation and recordkeeping. This role will adhere to established SOPs, work instructions, and templates to facilitate compliant program management and support the ongoing GxP Documentation needs of Tech Ops.

Responsibilities:

Perform Document controller activities in Veeva for all GMP controlled documentation, including policies, SOPs, and protocols, in alignment with established procedures.

  • Review, format, and approve manufacturing and quality records that support GMP operations in accordance with internal procedures.
  • Handle control, issuance, reconciliation, and archiving of GMP manufacturing and testing documentation, including batch manufacturing records and logbooks.
  • Ensure alignment to internal requirements while working in the Veeva QualityDocs system.
  • Support Quality and the broader Tech Ops team with any other GxP documentation requirements as needed.
  • Respond to requests from Tech Ops personnel to support the creation, revision, and/or obsolescence of GxP documents.
  • Act as the Veeva QualityDocs document controller, supporting ongoing implementation and configuration of EDMS in alignment with CARGO business requirements.


Requirements:

  • Degree in technology or life sciences with 2 years of relevant experience in the biotech or cell and gene therapy industry.
  • Experience working with Veeva Quality Vault.
  • Experience working with validated, GxP Document Management systems and interacting with vendors (e.g., Veeva).
  • Excellent command of MS Word and advanced features, plus the suite of Microsoft applications.
  • Understanding of document lifecycle management and application to internal processes.
  • Excellent knowledge of data integrity principles and their application in document management.
  • Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy and/or biologics.


Preferred Requirements:

  • Working knowledge of ICH guidance, regulatory guidance, and pharmaceutical organization guidance.
  • Strong familiarity working in support of biologics or cell/gene therapy manufacturing process and technology.



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