KINOVATE LIFE SCIENCES, INC · 11 hours ago
Quality Assurance Operations Supervisor
Oceanside, CA
Full-time
Onsite
Senior Level
5+ years expKinovate Life Sciences, Inc. is a market leader in solid support in the oligonucleotide synthesis field, committed to providing high-quality materials to niche life science markets. The Quality Assurance Operations Supervisor will sustain and improve the Quality Management Systems (QMS), manage quality assurance staff, and ensure compliance with relevant regulations while leading the implementation of MasterControl.
Pharmaceuticals
Hiring Manager
Jorge Barba
Responsibilities
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/Disposition
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
Upholds timely response to events and on-the-floor QA support(MQA), including ensuring the MQA program is tracked and measurable
Leads the transition of QMS programs, such as Quality Events (Deviation, CAPA, Change Control, OOS, OOT), Audits and Supplier Qualification transition into Master Control, and serves as the System Administrator
Administers post-implementation management of MasterControl, including, but not limited to, system optimization, performing troubleshooting support, managing software updates, and continuously improving system functionality to meet evolving regulatory needs
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
Supervises and develops a team providing guidance, training, and support to ensure compliance with regulatory standards and best practices
Mentors and develops a team of the QA team, fostering an environment of accountability and growth. Ensures cross-functional collaboration and provide effective leadership managing the QMS processes and ensures effective employee relations
Facilitates training initiatives to ensure that team members are adequately prepared to handle QMS functions and sustain a flexible workforce
Fosters a culture of continuous improvement, supporting staff development and efficiency improvements within the quality systems team
Conducts performance reviews for direct reports. Institutes timely corrective actions and interfaces with Leadership and HR in developing disciplinary actions up to and including terminations
Administers time-keeping functions to track absenteeism; approves timecards on a bi-weekly basis
Qualification
Required
Bachelor's degree in a scientific discipline; and five (5) years' directly related experience in a Good Practice (GXP) or ISO manufacturing-controlled environment or equivalent combination of education and experience
Experience in transitioning from paper based to electronic QMS
Working knowledge of pharmaceutical industry concepts, as well as analytical methods and writing skills, including documenting manufacturing processes, 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 MasterControl 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
Ability 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
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
Strong language skills with the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations
Write clear processes, manuals and reports for management review and present technical information in understandable terms and respond to questions from groups of customers, employees and/or public
Work independently as well as in a small and/or large group and foster cooperation in a team environment using interpersonal skills to document working knowledge
Work in a detail-oriented environment with strong follow-up, follow-through, and organizational skills
Preferred
Prior supervisory experience, preferred
American Society for Quality Certified, a plus
Certified Quality Engineer, a plus
Certified Quality Auditor, preferred
Benefits
Generous discretionary bonuses.
Health, dental, vision, life, and disability insurance effective from date of hire.
401(k)
3 weeks vacation in your first year
12 paid yearly holidays
5 paid sick days
Tuition reimbursement
More.
Company
KINOVATE LIFE SCIENCES, INC
Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California.
51-200 employees
H1B Sponsorship
KINOVATE LIFE SCIENCES, INC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase