Quality Systems Specialist III

teknova•Hollister, CA

11d•Onsite

About The Position

Join the Teknova Team and Help Shape the Future of Health. Our customers are working to discover novel therapies that will help people everywhere live longer, healthier lives. We make sure they have a reliable supply of the essential ingredients they need to succeed, and every member of our team plays an important role. OVERVIEW Reporting to the Sr. Manager, Quality Systems & Compliance, the Quality Systems Specialist III supports Teknova's supplier quality program, with a focus on the qualification of critical suppliers and the monitoring of supplier documentation for currency and renewal. This role works closely with purchasing and operations to resolve supplier quality issues and provides guidance on supplier management process enhancements and continuous improvement. This role owns Supplier Corrective Action Reports (SCARs) for Quality and focuses on driving other open quality events, such as complaints, change management, and audit findings, toward closure by following up with item owners, collecting status updates and supporting data, and serving as a liaison in related quality meetings. It maintains quality trackers (e.g., customer audits, SCARs, change management) and supports broader QMS activities, including Management Review metrics, complaints, risk management, and internal audit program administration, along with backup coverage for Quality Systems Specialist II duties as needed. Our Culture : At Teknova, our culture is all about creative problem solving, and our default answer is “Yes.” We’re customer-obsessed and go all in for them and each other. We aren’t interested in the status quo—we want to discover what’s possible. We’re bold and built to change. We go above and beyond to develop novel products that help our customers get reliable results, engineer formats that fit their systems, and find ways to ship out their orders one day sooner. Every time we help our customers work more efficiently; we bring them a step closer to that big breakthrough. Our Values : We value the unique personality and background of everyone on our team—we want you to be you. By working together and sharing our skills, we find new and better solutions for our customers. The people on our team are at the heart of everything we do, and we’re here to support them.

Requirements

Strong knowledge of quality systems, applicable sections of ISO 13485, and supplier quality management principles.
Presents quality status using Excel, Word, PowerPoint, or other suitable tools.
Embraces the principles and ethics described in the Teknova Guiding Principles and Quality Policy.
Bachelor's Degree in a related field with 5+ years of relevant experience; or High School Diploma with 5+ years of relevant experience; or an equivalent combination of education and experience.
Experience in a regulated manufacturing facility (e.g., applicable sections of ISO 13485).
Understanding of Good Documentation Practices (GDP) in a regulated environment such as ISO 13485.
Experience working with Electronic Document/Quality Management Systems (EDMS/eQMS) such as MasterControl, UNiPoint, or Propel.
Good oral and written communication skills.
Understanding of quality management systems and continuous process improvement principles.
Ability to organize and handle multiple projects concurrently; strong problem-solving capabilities.
Stands, walks, bends, carries, pushes, and uses both hands when performing assigned duties.

Responsibilities

Maintain and update supplier quality records, and liaise with Purchasing to obtain and maintain visibility into the Approved Supplier List (ASL) and Critical Supplier List.
Maintain policies, procedures, checklists, self-assessment surveys, and other forms for the supplier quality program.
Initiate, support, and progress Supplier Notices of Change within the Quality System.
Lead Change Control Review Board (CCRB) meetings, documenting decisions and tracking change requests through implementation, verifying updated documentation, and closing the change record.
Prepare Supplier Management reports for Quality Management Meetings.
Manage qualification of critical suppliers, including evaluation and onboarding per the supplier qualification program.
Monitor and track supplier documentation (e.g., certifications, quality agreements, questionnaires) received from suppliers, ensuring items remain current and flagging upcoming expirations for renewal.
Review SCAR responses and supplier quality documentation (e.g., quality agreements) for completeness and accuracy.
Participate in and support internal, supplier, customer, and certification-body audits, including preparation, on-site/remote involvement, responding to auditor requests, and authoring audit reports as applicable.
Verify compliance with company standards and applicable sections of ISO 13485.
Interact with certification bodies via email or in person to coordinate audit activities and relay follow-up responses.
Own and review Supplier Corrective Action Reports (SCARs) on behalf of Quality, from initiation through closure, including working with Purchasing and MSAT as needed on SCARs and Supplier Notices of Change to support change notifications.
Follow up on other open quality events, such as audit findings, complaints, and change management actions, collecting status updates and supporting documentation from item owners to drive timely closure.
Maintain quality trackers (e.g., customer audits, SCARs, change management), ensuring items are logged, status is current, and data is available for review; serve as a liaison in related quality meetings, relaying updates between item owners and leadership.
Maintain detailed reports on supplier quality performance and review supplier scorecards, SCARs, and other quality trends to determine whether further action (e.g., audits) is warranted.
Communicate with suppliers, customers, and certification bodies on assigned corrective actions and quality performance updates, relaying information to the appropriate internal stakeholders.
Support supplier execution of investigations, ensuring complete and accurate documentation.
Build and configure workflows in MasterControl (e.g., routing, approval steps, form fields), using the system's auto-validation feature to confirm proper setup before release.
Delivers end-user training on assigned MasterControl modules (e.g., supplier quality, SCARs, change control, audits) as well as general Quality Systems training topics, ensuring staff can navigate the system and complete required workflows accurately and on time.
Provide backup support for Quality Systems Specialist II duties (e.g., document control, change order processing, complaints, training administration) as needed.
Support Management Review by compiling and trending QMS metrics (e.g., audit findings, SCARs, scorecards) for presentation to leadership.
Support risk management activities (e.g., FMEA, risk assessments) by compiling and organizing relevant data for QMS and product/process changes, where applicable.
Maintain and help administer the internal audit schedule/program, ensuring audits are planned, resourced, and completed on schedule.
Coordinate audit calendars and planning, including customer and certification-body audits, working with the Sr. Manager and Account Executives as needed.
Perform other Quality Systems and supplier-quality tasks as assigned.