Document Control Specialist

CMC · Santa Ana, California
Department CMC
Employment Type Full-Time
Minimum Experience Mid-level

Job Title

Document Control Specialist

 

Job Summary

 

NKGen Biotech is seeking a highly motivated individual to join us as a Quality Assurance 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 Head of Quality Assurance.


General Responsibilities

 

  • Maintain a document management system compliant with GMP Quality Systems, ICHQ10, and NKGen Biotech requirements.
  • Responsible for the management of all lot documentation and records issuance processes to support clinical and commercial manufacturing.
  • Responsible for the routing, review, approval, distribution and archival of new and revised controlled documents.
  • Manage the creation, review, and revision of SOPs and training documentation for the document control department.
  • 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.

 

*The company reserves the right to add or change duties at any time.

 

Job Qualifications & 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 (Solabs, 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).

 

Benefits & Perks

 

  • Competitive compensation
  • Medical, Dental and Vision Insurance
  • Business casual work attire
  • Fully stocked kitchen and much more!

Thank You

Your application was submitted successfully.

  • Location
    Santa Ana, California
  • Department
    CMC
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level