Quality Systems Specialist I

Teknova Inc; Hollister (CA); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401(k) with match

ESPP

Wellness program

Learning opportunities

Paid time off

Job summary

Teknova is seeking a Quality Systems Specialist I - Document Control to maintain change orders, control documents, and support the QMS. You will review records, draft COAs, SDSs, and ensure compliance with GMP and regulatory standards.

The role includes internal audits, training support, and assisting with external audits, reporting to the Quality Systems and Compliance Manager. You will collaborate with cross-functional teams to maintain accurate documentation, and help drive continuous

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• Experience in a Document Control position within a Medical Device, Pharmaceutical, Biotech, or regulated company preferred.
• Understanding of Good Documentation Practices in a regulated environment such as ISO 13485, ISO 9001, and/or 21 CFR 820.
• Fundamental and working knowledge of computers, including MS Office applications (i.e. MS Word, MS Excel, etc.)
• Experience working with both Manual DC Systems, and EDMS such as MasterControl, UNiPoint, Propel.
• Good human relations and oral/written communication skills.
• Ability to organize and handle multiple projects concurrently Strong problem-solving capabilities.

Responsibilities

• Process routine DCOs/PCOs using established procedures.
• Draft, review, and approve templates, COAs, SDSs and supporting documentation to ensure GMP/compliance.
• Maintains controlled documentation, protocols, and reports.
• Supports processing of non-DC systems such as Training, Change Control, and QMS CAPAs.
• Supports processing of change control orders in the eQMS and provides support to QS team.
• Compiles and reviews routine DC data and trainings completed through the QMS.
• Runs established reports and compiles DC metrics for management review.
• Provides guidance on eQMS functions and escalates complex questions.
• Provides insights to improve eQMS models for the organization.
• Delivers predefined training for DCO/PCO Teknova Training and supports New Hire Orientations.
• Assists leaders with training plans and CAPA-related tasks.
• Performs basic internal audits and issues findings with closures.
• Assists with external audit preparation and coordinating audits.
• Supports quality efforts by enforcing change and compliance.
• Performs various quality systems and administrative tasks.

Skills

Document Control

GMP compliance

ISO 13485

ISO 9001

21 CFR 820

MS Office

MasterControl

UNiPoint

Propel

Communication skills

Education

Bachelor’s Degree

Tools

MasterControl

UNiPoint

Propel

MS Office

Job description

Description

Join the Teknova Team and Help Shape the Future of Health

When you join the Teknova team, you’re helping to create 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.

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’re not 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.

JOB OVERVIEW

The Quality Systems (QS) Specialist I - Document Control (DC) will be responsible for the routine creation and maintenance of change orders (Document Change Order / Process Change Order – DCO / PCO, Other) following pre-defined parameters and processes. Including the review and approval of companywide documents and records. This role will help maintain the quality management system (QMS) through prompted document creation/management, good documentation practices, change order maintenance, internal auditing, QMS CAPA (Corrective and Preventive Action) support, and external audit preparation. This role will also support training for new hires, and maintenance of associated records. This position reports to the Quality Systems and Compliance Manager.

JOB DUTIES AND RESPONSIBILITIES

• Processes routine DCO’s and PCO’s using established procedures (reviewing for completeness, approving and releasing); escalates unusual or complex requests for review. Formats detailed information provided by stakeholders into predefined formats to establish new and/or revised written procedures including redline verification and/or approval of documents, or records
• Drafts, reviews, and approves templates, formulation sheets, BOMs (bills of materials), COAs certificates of analysis), SDSs (safety data sheets) and any supporting documentation using predefined procedures and parameters to ensure compliance with GMPs (Good Manufacturing Practices) and Teknova policies and procedures.
• Maintains controlled documentation, protocols, and reports in accordance with established procedures.
• Supports processing of non-DC systems such as Training, Change Control, and QMS CAPAs, as directed.
• Supports processing of change control orders in the eQMS and provides support to QS team managing change controls, as directed
• Compiles and reviews routine DC data related to DCOs/PCOs, and trainings completed through the QMS, escalates discrepancies and/or trends for review.
• Runs established reports and compiles DC and training metrics/data for management review.
• Establishes sufficient working knowledge to provide routine guidance on functions and fields within the eQMS, escalates complex non-routine questions.
• Provides insights and feedback to identify ways to improve the eQMS models to better work for the QMS and the organization.
• Delivers a pre-defined training to users who will perform DCO/PCO/Teknova Training and supports New Hire Orientations.
• Assists leaders in ensuring that existing and new associates have appropriate training plans assigned. Completes changes as appropriate, and as requested by line managers and other leaders. Supports QS CAPAs pertaining to audit findings and/or continuous improvement efforts.
• Performs basic internal audits of the organization, following predefined checklists comparing written procedure documents to performed procedures, authors audit reports, issues findings, and tracks finding closures/CAPAs.
• Assists with external audit preparation including coordinating audits with the QS team, preparing audit files, reviewing audit files, and supporting the team leading external audits.
• Supports quality efforts throughout the organization by following and enforcing change and compliance.
• Performs various tasks as assigned, including Quality Systems and administrative tasks related to the QMS.

to successfully complete projects.

Requirements

EDUCATION

• Bachelor’s Degree in related field or equivalent combination of education and experience preferred

KMOWLEDGE / SKILLS / EXPERIENCE

• Experience in a Document Control position within a Medical Device, Pharmaceutical, Biotech, or regulated company preferred
• Understanding of Good Documentation Practices in a regulated environment such as ISO 13485, ISO 9001, and/or 21 CFR 820.
• Fundamental and working knowledge of computers, including MS Office applications (i.e. MS Word, MS Excel, etc.)
• Experience working with both Manual DC Systems, and EDMS (Electronic Data Management Systems) such as MasterControl, UNiPoint, Propel.
• Good human relations and oral/written communication skills.
• Ability to organize and handle multiple projects concurrently Strong problem-solving capabilities.

Benefits

From performance bonuses that give every member of our team a chance to share in our success to health insurance and retirement savings programs to our generous PTO policy, we’re invested in our associates. Our benefits include:

• Comprehensive medical, dental, and vision plans
• 401(k) retirement plans with a 4% employer match
• Employee Stock Purchase Plan (ESPP)
• Teknova wellness program
• Continuous learning opportunities
• Paid holidays, paid time off, and paid sick leave

From our scientists to our shipping department, the people who thrive here see beyond reporting lines—they are driven and open to learning something new. If you’re ready to make a difference and be part of a team that values creativity, collaboration, and customer obsession, we’d love to hear from you. Join us at Teknova and help shape the future of health.

Teknova is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other status or characteristic protected by law.