Document Control Specialist - FT - Santa Ana

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