Quality Systems & Documentation 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

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