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.
- 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