Sr. QA Specialist
The Sr. QA Specialist supports NKMax America throughout the product development and commercial life cycle, by facilitating quality activities and coordinating company-wide interactions. This is accomplished with a thorough understanding and knowledge of quality requirements to support and ensure that NKMax America operates within and in compliance with applicable regulations.
This role will be responsible for working closely with the Director of Quality Assurance, with planning and coordinating all quality-related activities from pre-submission, including providing input to the Company's development plans of its investigational products, to commercialization of product. The role will be responsible for assessing quality requirements and ensure NKMax America to be responsible in complying with these requirements.
- Provides quality oversight to internal manufacturing and testing operations with respect to the proper administration and adherence to all policies, procedures, and applicable regulations
- Ensure NKMax America vendors execute appropriate Quality Systems to sustain a state of cGMP compliance for NKMax America raw materials, components, and reagents
- Initiate, review, and approve GMP related policies and SOPs
- Active participant in audits and inspection readiness activities to ensure NKMax America is in a constant state of inspection readiness
- Provide appropriate notification to management of quality issues
- Review and approve of company quality records, cGMP documents -such as batch records, analytical and manufacturing validation protocols and reports, process & laboratory change controls, investigation, and reconciliation of deviations.
- Responsible for release of clinical products and appropriate management of product complaints.
- Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation.
- Monitor effectiveness of implemented corrective actions and improvement initiatives.
- Monitor trends in metrics of key quality systems (e.g. Deviations, Complaints, Change Controls, training) to identify opportunities for CAPA.
- Be available for consultation on quality-related issues as needed.
*The company reserves the right to add or change duties at any time.
- Excellent written and verbal communications skills. Regulatory writing experiences is a must.
- Strong time and project management skills; highly detail oriented.
- IND filing experience; pre-IND to BLA lifecycle experience.
- Comprehensive US and global regulatory knowledge for cell therapy products and knowledgeable in industry trends for regulatory affairs, biologics is transferrable.
- Experience interacting and responding to regulatory bodies (FDA, EMA, and other national authorities)
- 10+ years of experience in pharmaceutical industry with at least 5 years of Quality Assurance
- 5+ years’ experience in Quality
- Strong understanding of GMP and quality systems
- Must have great attention to detail
- Must be able to effectively collaborate with others and work in a matrixed team
- Ability be flexible, resourceful, and multitask efficiently
- Experience in cGMP auditing and FDA inspections
- Strong working knowledge of cGMPs and technical expertise in quality systems required.
- Understanding of Quality by Design principles and control strategy preferred.
- Experience with multiple aspects of the process development, analytical characterization, process scale-up, and/or regulatory registration of drug products
- Understanding of good clinical/laboratory or manufacturing practices and regulatory compliance
- Must have excellent computer, technical writing and verbal communication skills.
- Must be able to effectively collaborate with peers and comfortable working in a matrixed team
- Must be solutions oriented and pragmatic
- Excellent project management skills are a must
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!