Careers

Full job description

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) 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. KLS is proud to be an equal employment opportunity 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:

Under strategic leadership and an integral member of the site leadership team, lead the Quality Assurance Business Unit to enhance business performance and drive positive continuous improvement culture. Partner with other Nitto manufacturing sites to achieve Same Products/Same Quality (SPSC) business objectives. Develop well-defined quality standards, specifications, and operator self-inspection methodologies to raise the performance of the company’s product lines, promoting customer satisfaction, on-time delivery, and business excellence. Play key role in developing site business strategy, collaborating with Process Development, Engineering & Operations, Procurement and Human Resources Management.

ESSENTIAL DUTIES and/or RESPONSIBILITIES:

• Provides site leadership to meet and improve product quality and operation quality standards, engaging employees to achieve business objectives.
• Leads and manages the Quality team to achieve key indicator results supporting the business objectives, goals, and strategies.
• Directs department staff in the performance of their essential functions and complete related Human Resources activities, including recruiting, interviewing, selecting, coaching, mentoring, training, performance reviews and employee relations.
• Develops, manages, and sustains, the Quality Management Systems to meet applicable Regulatory requirements, such as ISO, FDA, QSR, US and INTL regulations and International Quality Standards, as applicable.
• Ensures customer quality satisfaction through the implementation and use of programs(e,g,MasterControl) to control raw materials, in-process materials, production processes, environmental conditions, and finished products to meet customer quality expectations and requirements.
• Secures timely closure of deviations, change controls, Corrective/Preventive Actions (CAPA) and complaints. Develops strategies for continuous improvement.
• Contributes to internal and external audit programs; ensures audits are completed accurately and within the deadline. Participates in third party external inspections/audits, serving as primary audit host for KLS.
• Manages a formal corrective action system to corroborate root cause analysis and continuous improvement (Kaizen) objectives. Assures timely responses to external and internal customer requests, statements of non-compliance, or complaints, and confirms appropriate corrective action.
• Plans and oversees analysis of statistical data and product specifications to determine present standards and monitors Quality and reliability expectancy of finished product.
• Partners with departments across the a cross-functional matrix & external stakeholders as appropriate and ensures senior leadership is informed of any serious complaints.
• Develops and delivers training programs that teach appropriate use of Quality Tools.

ESSENTIAL DUTIES and/or RESPONSIBILITIES (continued):

• Supervises and develops a team of Quality Assurance Supervisors and Specialists 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.
• Executes 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 evaluations of direct reports. Institutes timely corrective actions and interfaces with Leadership and HR in developing disciplinary actions up to and including terminations.
• Other duties as assigned.

SUPERVISORY RESPONSIBILITES:

• Quality Operations Supervisor
• Quality Systems Supervisor
• Quality Assurance Specialist (all levels)
• Quality Systems Specialist (all levels)

MINIMUM EDUCATION and/or EXPERIENCE:

• Bachelor of Science degree in a technical field or related subject; and 7-years’ directly related experience in QA/QC position; Master of Science degree, a plus.
• Ten (10) years’ leadership experience in a highly regulated manufacturing operations and quality assurance environment, preferably in the pharma industry; or an equivalent combination of education and experience.

KNOWLEDGE, SKILLS and/or ABILITIES:

• Demonstrated success in leading a hands-on quality culture and performance transformation focused on disciplines QMS management execution and a proactive quality culture of personal accountability, sound judgment, empowerment, and pride in performance.
• Working knowledge of regulations/guidelines in partner industries (such as ISO 9001, ISO 134385, ICH Q7, FDA 21 CFR Part 210-211).
• Demonstrated proficiency in managing the integration and deployment of lean manufacturing principles within an organization along with customers, required.
• Excellent working knowledge of Quality principles, concepts, methodologies, and techniques as well as chemistry concepts; above average understanding of solid support and oligonucleotide synthesis.
• Robust application of critical thinking skills along with exceptional problem-solving skills to identify root cause analysis.
• Clear multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment. Work in a detail-oriented environment with strong follow-through and organizational skills.
• Solid ability to verbally communicate across functional organizational groups, provide high-level customer service through effective interpersonal skills and conflict resolution.
• Strong Microsoft Office Suite software applications such as Excel, Word, Power Point and other enterprise software applications like MasterControl or equivalent electronic Quality Management System.
• 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 well in a small and/or large group and foster cooperation in a team environment using interpersonal skills.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram forms.

CERTIFICATES and/or LICENSES:

• Lean Six Sigma, desirable.
• Certified Quality Auditor, desirable.

PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Position works in an office environment involving prolonged sitting in front of a computer workstation, speaking, listening, reading, and writing and low-level noise.
• Domestic and international travel to Japan, Asia, Europe, and the Middle East may be required, up to 10% of the year.
• Communication with overseas offices and/or customers in different time zones requires flexible availability, including early morning or late night, as necessary.
• Ability to work under demanding requirements and hard deadlines (e.g., product deliverables).
• Must be able to work extended hours per the demands of the business.

Full job description

Kinovate Life Sciences, Inc. established in 2004 in Oceanside, California. A wholly owned subsidiary of Nitto Denko Corporation (www.nitto.com), Kinovate was spun-off from Oceanside, CA based R&D facility Nitto Denko Technical Corp (www.ndtcorp.com) 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. KLS is proud to be an equal employment opportunity 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:

The Facilities Associate maintains and ensures the operational readiness of the KLS Facilities. The job includes a range of responsibilities, from routine maintenance and repairs to managing supplies and supporting staff needs. The position contributes to a safe, efficient, and well-functioning facility and building.

ESSENTIAL DUTIES and/or RESPONSIBILITIES:

1. Performing routine inspections, maintenance tasks, and repairs on building systems, equipment, and grounds. This could involve plumbing, electrical, HVAC, Air compressors, Power Generators, and general upkeep.
2. Maintain a safe work environment by observing & enforcing OSHA, HAZMAT, NFPA and KLS EHS requirements.
3. Conducting safety checks, identifying hazards, and implementing safety protocols. They may also be involved in access control and security measures.
4. Maintaining a clean and sanitary environment by cleaning floors, surfaces, restrooms, and emptying trash.
5. Managing inventory of supplies, ensuring adequate stock levels, and potentially ordering new supplies.
6. Assisting with setting up and arranging spaces for meetings and events and restocks kitchen and breakrooms.
7. Performs cautious deep and specialized cleaning of production rooms and labs while focusing on the integrity of production’s and labs’ equipment.
8. Responding to facility-related requests, communicating with staff, and liaising with vendors and contractors.
9. Maintaining records of maintenance activities, inspections, inventory, and other relevant data.
10. Transloading hazardous materials from bulk tanker trucks into storage tanks and from storage tanks into bulk tanker trucks, following all internal and external regulations.
11. Ensures that EHS and ESG guidelines are strictly followed.
12. Other duties as assigned.

MINIMUM EDUCATION and/or EXPERIENCE:

1. High school diploma with Technical Trade Certificate or equivalent required.

KNOWLEDGE, SKILLS and/or ABILITIES:

1. At least five years of maintenance/facilities in an industrial and laboratory environment experience required.
2. Extensive knowledge of industrial process equipment, hazardous materials tank farm and building systems.
3. Ability to prioritize tasks and to plan and schedule them as necessary.
4. Ability to identify issues and to determine repairs that are needed.
5. Ability to plan maintenance schedules.
6. Strong communication skills.
7. Proficient with Microsoft Office Suite or related software as needed to complete reports, logs, and inventory. Experience using Computerized Maintenance Management System (CMMS)
8. Experience working on an operating site and high hazard site.
9. Experience with NFPA, OSHA, cGMP and ISO standards.
10. Experience reading P&ID, PFD, and other technical drawings.
11. Self-motivated with strong initiative and drive to succeed. With excellent interpersonal skills, will be able to work effectively in a team and on their own initiative.
12. Excellent problem solving skills.
13. Must be proficient in IT (Office packages).
14. English language.

CERTIFICATES and/or LICENSES:

1. Forklift and HAZWOP certification, a plus.

PHYSICAL DEMANDS and/or WORK ENVIRONMENT: (Typical physical demands and the work environment characteristics an employee must meet and encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

1. This position requires occasional sitting at a desk, up to 3 hours a day, using a computer.
2. Must be able stand/walk frequently up to 6 hours a day to observe machines, conduct rounds, and record log entries.
3. Ability to frequently lift and carry items up to 50 pounds.
4. Ability to bend and twist at the waist/squat/kneel/crawl/climb occasionally up to 3 hours a day.
5. Ability to push, pull, and reach occasionally, up to 3 hours a day.
6. Ability to deviate wrist (side to side) and conduct hand/wrist repetitions (up and down) occasionally, up to 3 hours a day.
7. Ability to firmly grasp objects with a force greater than 50 pounds.
8. Gross motor hand manipulation of moderate-heavy strength is required to use various tools.
9. Fine hand manipulation of light-moderate strength is required to operate touch screen displays.
10. Must be able to see/focus for close eye work (small figures), discriminate colors, and perceive depths.
11. Must be able to speak/hear verbal communications and respond to machine alarms/buzzers.
12. Subject to periodic exposures to varying temperatures, occasional exposure to noise levels above 85 decibels, gas/fumes/mists, and chemicals or hazardous materials while using personal protective equipment when required.
13. May be exposed to crawl spaces/cramped positions up to 1 hour/day.
14. Must wear safety shoes in required areas.
15. Must be able to work extended hours per the demands of the business, this will also include Mandatory Production Weekend Overtime.