Hiring: Quality Assurance Operations Supervisor Company: KINOVATE LIFE SCIENCES, INC Location: Carlsbad, CA Job Posted Time: 2026-09-15 15:12:53 Target Skills & Keywords : Microsoft Excel, Microsoft Office, Quality Assurance, R, Root Cause Analysis, Six Sigma About the job Required Skills: •Partners with leadership to develop the Quality Management System (QMS) and ensure it is compliant with relevant regulations, including ISO 9001, 21 CFR Part 210 and 211, ICH, and other applicable national and international regulatory guidelines. •Ensure the QMS always remains in an auditable state. •Oversees the daily operations of the QMS, ensuring it runs efficiently and in compliance with quality standards. This includes managing critical quality systems processes such as Incoming Raw Material Receipt, Raw Material Review/Disposition, Final Product Review/Dispositon. •Manages quality events and investigations including but not limited to Deviations, CAPA, Change Control, OOS, OOT, Customer Complaints, including leading and facilitating cross-functional meetings to ensure proper assessments and actions. •Ensures QA review of Validation/Qualification activities including protocols, execution, and reports. •Reports key metrics for QA Operations turnaround times and Quality Events. Contributes to the continuous improvement initiatives related to the QMS, collaborating with cross-functional teams to optimize quality processes. •Analyze quality data and metrics to identify trends, root causes, and areas for process improvement within manufacturing and quality control activities. •Develops standard operations and other quality documents related to QMS and ensure all documents meet regulatory requirements and internal standards. Qualifications: •Solid functional working knowledge of pharmaceutical industry concepts, as well as analytical methods and writing skills, including documenting manufacturing processes, a plus. •Familiarity in Lean or Six Sigma, a plus. Strong Knowledge of quality management principles and practices, including ISO 9001 and cGMP standards. •Proficient in the use of quality management software with experience in implementing or managing Master Control being highly desirable. Experience conducting technical investigations with formal root cause analysis tools. •Knowledgeable of change control, validation/qualification, and method development and tech transfer. •Strong knowledge of formal root cause analysis and risk assessment tools. •Demonstrated capacity to lead or facilitate investigations and/or risk assessments. •Strong application of critical thinking skills along with problem solving and creative skills to identify manufacturing issues for continuous improvement. •Strong multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment. •Strong ability to verbally communicate across functional organizational groups, provide high-level customer service through effective interpersonal skills and conflict resolution, including communicating with equipment suppliers to obtain input on equipment modification and improvement. •Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as Net Suite, LIMS, and Familiarity with statistical analysis tools. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!