Job Description

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. 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, sustain the improvement of the Quality Management Systems (QMS) and manages the development of quality assurance & systems staff. Utilize the following industry standards to drive high-quality products: Current Good Manufacturing Practice (cGMP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and International Organization for Standardization (ISO). Facilitate employee relations issues including coaching, mentoring, and disciplining including performance evaluation of employees. Provides strong leadership to motivate, guide and inspire employees to meet the organization’s business objectives with production. Lead the implementation phase of MasterControl, ensuring successful implementation, and post-implementation management.

ESSENTIAL DUTIES and/or RESPONSIBILITIES:

1. 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.
2. 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.
3. 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.
4. Ensures QA review of Validation/Qualification activities including protocols, execution, and reports.
5. Upholds timely response to events and on-the-floor QA support(MQA), including ensuring the MQA program is tracked and measurable.
6. 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.
7. 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.
8. Reports key metrics for QA Operations turnaround times and Quality Events.
9. 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.
10. Develops standard operations and other quality documents related to QMS and ensure all documents meet regulatory requirements and internal standards.
11. Supervises and develops a team providing guidance, training, and support to ensure compliance with regulatory standards and best practices.
12. 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.
13. Facilitates training initiatives to ensure that team members are adequately prepared to handle QMS functions and sustain a flexible workforce.
14. Fosters a culture of continuous improvement, supporting staff development and efficiency improvements within the quality systems team.
15. 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.
16. Administers time-keeping functions to track absenteeism; approves timecards on a bi-weekly basis.

SUPERVISOR RESONSIBLITIES:

1. Quality Assurance Associate
2. Quality Assurance Specialist
3. Sr. Quality Assurance Specialist

MINIMUM EDUCATION and/or EXPERIENCE:

1. 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.
2. Experience in transitioning from paper based to electronic QMS.

KNOWLEDGE, SKILLS and/or ABILITIES:

1. 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.
2. Strong Knowledge of quality management principles and practices, including ISO 9001 and cGMP standards.
3. Proficient in the use of quality management software with experience in implementing or managing MasterControl being highly desirable.
4. Experience conducting technical investigations with formal root cause analysis tools.
5. Prior supervisory experience, preferred.
6. Knowledgeable of change control, validation/qualification, and method development and tech transfer.
7. Strong knowledge of formal root cause analysis and risk assessment tools. Ability to lead or facilitate investigations and/or risk assessments.
8. Strong application of critical thinking skills along with problem solving and creative skills to identify manufacturing issues for continuous improvement.
9. Strong multi-tasking skills, flexibility in responding to rapidly changing, dynamic processes and demands/pressures in a fast-paced environment.
10. 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.
11. 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.
12. Strong language skills with the ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations.
13. 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.
14. 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.
15. Work in a detail-oriented environment with strong follow-up, follow-through, and organizational skills.

CERTIFICATES and/or LICENSES:

1. American Society for Quality Certified, a plus.
2. Certified Quality Engineer, a plus.
3. Certified Quality Auditor, preferred.

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. Works in a typical office environment with prolonged periods in front a computer entering or researching data.
2. Regularly required to sit; use hands to finger, handle or feel and talk or hear.
3. Availability and willingness to travel if required for audits, inspection, vendor management or if requested to visit or attend a business transaction as legal agent of the company.
4. Must be able to work extended hours per the demands of the business.

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