Sr. Quality Systems Specialist

Under general guidance, the Senior Quality Systems Specialist will collaborate with leadership to champion, sustain and continually improve the Quality Management System (QMS) of Kinovate Life Sciences. Contributes to customer audits and external inspections of the QMS by providing backroom support. Utilizes the following industry standards and regulatory frameworks to guide the development and maintenance of the QMS in support of our shared goal of delivering high-quality products to our customers: International Organization for Standardization (ISO 9001:2015), Current Good Manufacturing Practice (cGMP), and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Adheres to internal policies, procedures, and customer requirements.

Essential Duties and/or Responsibilities:

1. Partners with leadership in the development, implementation, and management systems in compliance with relevant regulations and standards (e.g., ISO 9001).
2. Serves as a system administrator of the electronic QMS (MasterControl) and provides training to staff across the organization on requirements of the QMS.
3. Manages the document control program, including the creation, revision, distribution and archival of records, policies, procedures, and other documents.
4. Leads and conducts internal audits in accordance with the requirements of the Internal Audit program.
5. Manages the approved supplier list, ensuring suppliers are evaluated and categorized based on risk while contributing to supplier assessments and routine qualification audits in accordance with the requirements of the Supplier Management program.
6. Conducts root cause analysis in support of the investigation of quality events and deviations related to the QMS.
7. Provides training to employees and new hires specific to the functions of the QMS and related policies and procedures.
8. Manages the training program to ensure successful training record-management and compliance to training requirements.
9. Serves as a subject matter expert (SME) for quality systems-related inquiries.
10. Directly contributes to the review and processing of customer quality questionnaires, ensuring proper approvals are obtained from management and the legal department.
11. Ensures the compliance of the QMS is maintained by keeping up with industry regulations and standards through continuing education.
12. Analyzes data and metrics to identify trends, deviations, and opportunities for continuous improvement.
13. Other duties as assigned.

MINIMUM EDUCATION and/or EXPERIENCE:

1. Bachelor’s degree in a scientific discipline; and at least five (5) years of Quality Systems experience in an ISO regulated manufacturing environment, or equivalent combination of education and experience.
2. Experience with internal and external audits and processes, including root cause analysis and corrective action implementation.
3. Experience transitioning from paper-based QMS to an electronic QMS preferred.

KNOWLEDGE, SKILLS, and/or ABILITIES:

1. Working knowledge of ISO 9001:2015 and pharmaceutical industry regulations as they relate to the management of quality systems.
2. Direct experience with MasterControl, preferred. Experience as a system administrator, a plus.
3. Detailed knowledge of core quality management principles, including document control, supplier qualification, change control, validation/qualification, method development, and tech transfer.
4. Adept at root cause analysis with the ability to lead investigations and develop effective corrective action plans.
5. Direct experience conducting internal and/or external audits.
6. Exhibits flexibility in responding to changes in work priorities.
7. Effective in managing a routine workload while balancing the demands of long-term projects and process improvements.
8. Highly effective verbal and written communication across functional groups within the company as well as with external parties including customers and suppliers.
9. Highly refined interpersonal skills, enabling the ability to foster trust and efficiently resolve conflicts.
10. Intermediate to expert proficiency with Microsoft Office Suite software applications such as Excel, Word, Power Point, and other enterprise software applications such as NetSuite, Electronic Quality Management (EQMS or EDMS) software (e.g., Master Control, preferred). Familiarity with statistical analysis tools.
11. Strong reading comprehension skills with the ability to analyze and interpret general business periodicals, professional journals, technical procedures, statutes, and regulations.
12. Strong writing skills, with prior experience authoring and revising instructional documents, policies, and procedures.
13. Responds directly, accurately, and completely to requests for information or guidance.
14. Ability to work independently as well as in a small and/or large group and foster cooperation in a team environment using interpersonal skills.
15. Work in a detail-oriented environment with strong follow-up, follow-through, and organizational skills.
16. Familiarity with Lean, 5S, or Six Sigma, a plus.

CERTIFICATES and/or LICENSES:

1. American Society for Quality Certified, a plus.
2. Certified Quality Engineer, a plus.
3. Certified Auditor, 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. 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. Must be able to lift to 50 pounds with assistance.
4. Availability and willingness to travel if required as part of supplier management or if requested to visit or attend a business transaction as legal agent of the company.
5. Must be able to work extended hours per the demands of the business.
6. Position onsite in Carlsbad California

**Visa sponsorship is not eligible for this position.