Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation , Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp with a mission to provide the highest quality materials to niche life science markets worldwide.
Since its inception, Kinovate has grown to become the market leader in solid support in the oligonucleotide synthesis field. We are bringing the most creative minds in science and technology to develop medical discoveries and breakthroughs. Our customers are well-known in the biotechnology industry. We are in a growth phase within ISO work environment and leading towards a GMP Certification. KLS is seeking extraordinary people to join the team. We are proud to be an EEO employer
Why Work Here Great place to work. Small subsidiary of large international company headquartered in Japan. Generous discretionary bonuses. Health, dental, vision, life, and disability insurance effective from date of hire. Additional benefits include 401(k), 3 weeks vacation in your first year, 12 paid yearly holidays, 5 paid sick days, tuition reimbursement and more.
JOB SUMMARY
We are seeking a senior level, detail-oriented and proactive Quality Assurance Specialist to join our dynamic Quality Assurance team. The ideal candidate will be responsible for maintaining and improving quality management systems and ensuring compliance with industry standards. This role is vital in supporting our commitment to delivering high-quality products and services.
ESSENTIAL DUTIES and/or RESPONSIBILITIES
1. Quality System Management -Develop, implement, and maintain quality management systems in compliance with relevant regulations and standards (e.g., ISO 9001, FDA, etc.). Support the transition to a new electronic QMS. Support the training of other personnel on quality functions.
2. Change Control -Provide quality oversight over the initiation, documentation, assessment and implementation of change controls. Work cross-functionally with other departments to ensure proper assessment and execution prior to change implementation.3. Deviations/CAPAs/OOS - Lead or provide quality oversight in the initiation, documentation, assessment and management of quality events (e.g. deviations, CAPA, risk assessments,). Perform root-cause analysis and other problem solving activities utilizing appropriate failure investigation tools (e.g. 5 "Whys", Fishbone, 6M's etc.) to identify effective corrective and preventative actions, measures and process improvements.
4. Validation/Qualification - Conduct quality review of documentation including test protocols, summary test reports, IQ/OQ/PQ reports and data for process, test method, equipment, facilities, software or other system validation and qualification activities. Review of test method development and transfers. Experience with cleaning verification and validation.
5. Batch Record Review -Perform raw material and final product batch record review (including batch records, CoAs and other related documents) for each KLS product lot.
6. Metrics - Maintain/generate quality metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.
7. Continuous Improvement - Participate in the design, implementation and documentation of procedures for process control, process improvement, testing and inspection.
8. Audits - Independently perform internal audits. Participate in external quality audits.
9. Other duties as assigned.
MINIMUM EDUCATION and/or EXPERIENCE
- Bachelor's degree in Science, Engineering, Life Sciences, or a related field and 5+ years' experience in Quality Assurance or equivalent combination of education and experience.
KNOWLEDGE, SKILLS and/or ABILITIES
- Strong knowledge of quality management principles and practices, including ISO and GMP standards.
- Strong knowledge in change control, validation/qualification, and method development and tech transfer.
- Strong knowledge of formal root cause analysis and risk assessment tools. Ability to lead or facilitate investigations and/or risk assessments.
- Experience conducting internal and/or external audits a plus.
- Excellent analytical skills and attention to detail.
- Strong communication and interpersonal skills, with the ability to work collaboratively across teams.
- Experience working with electronic quality management software(preferably MasterControl) and Microsoft Office Suites.
- Experience transitioning from paper based to electronic QMS.
CERTIFICATES and/or LICENSES
- Certification in quality management and/or auditing (e.g., ASQ Certified Quality Auditor, ISO Lead Auditor.
- Experience with Lean or Six Sigma methodologies.