Quality Systems Specialist I: Document Control & Compliance

Teknova-

Hollister (CA)

On-site

USD 70,000 - 90,000

Full time

7 days ago

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Benefits offered by this job

Medical, dental, and vision plans

401(k) with 4% employer match

Employee Stock Purchase Plan (ESPP)

Wellness program

Continuous learning opportunities

Paid holidays and PTO

Job summary

Teknova seeks a Quality Systems Specialist I—Document Control to manage DCO/PCO workflows, maintain QMS records, and support audits. You’ll draft templates, review documents, train new hires, and help ensure compliance with GMPs and ISO requirements at our Hollister, CA site.

This role collaborates with cross-functional teams to improve eQMS processes and ensure timely approvals and training completion. A background in regulated environments and strong documentation skills are essential for

Qualifications

Experience in a document control role in regulated industries.
Understanding of Good Documentation Practices in a regulated environment.
Familiarity with EDMS and QA documentation.
Strong communication and organizational skills.

Responsibilities

Process DCO/PCO tasks using established procedures and escalate for review as needed.
Draft, review, and approve templates, COAs, SDSs and related documents.
Maintain controlled documentation, protocols, and reports per procedures.
Support non-DC systems like Training, Change Control, and CAPAs.
Assist with external audit preparation and deliver QS training.