Document Control Specialist – FT – Santa Ana, CA

Job Summary

NKMax America is seeking a highly motivated individual to join us as a Sr. Document Control Specialist.  Implement quality systems associated with Document Management with a focus on batch record documentation issuance and process enhancements that ensure right first time. This position will report to the SVP Quality and Technical Operations.

General Accountabilities

  • Maintain a document management system compliant with GMP Quality Systems, ICHQ10, and NKMax America requirements.
  • Responsible for the management of all lot documentation and records issuance processes to support clinical and commercial manufacturing.
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the lot document management system.
  • Responsible for enhancing and maintaining the document change control system for batch record issuance and label issuance.
  • Collaborates with cross-functional departments to ensure timely implementation of changes to the batch record and label issuance system.
  • Prints, compiles and issues all lot related documentation (batch records, labels, sample plans, specifications etc.)
  • Investigates deviations against the lot documentation and records issuance system and develops effective corrective action plans.
  • Develops or enhances training content for batch record and label issuance processes and procedures.
  • Provides training to new staff on batch record and label issuance processes and procedures.
  • Quality record owner (deviations, CAPA, CC) associated with batch record and label issuance processes and procedures.
  • Perform other duties as required.

Job Qualifications and Skills

  • Bachelor’s degree and a minimum of 4 years of experience OR Master’s degree and a minimum of 2 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
  • Strong knowledge of GMP, SOPs and quality system processes.
  • Excellent organizational skills and ability to review processes or procedures.
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent).
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Experience in pharmaceutical or bio-pharmaceutical field.
  • Education or training in cell culture and gene therapy manufacturing environment a plus.
  • Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
  • If required, may occasionally need to work on weekends