Document Control & QMS Specialist I

Teknova; Hollister (CA); On-site; USD 34,000 - 49,000; Full time

Benefits offered by this job

401(k) retirement plans with 4% match

Employee Stock Purchase Plan (ESPP)

Wellness program

Paid holidays and PTO

Job summary

Teknova in Hollister, CA seeks a Quality Systems Specialist I - Document Control to maintain change orders and support the QMS. You will review company-wide documents, manage records, and assist with audits and training.

The role involves drafting/reviewing templates and COAs, maintaining controlled docs, and providing guidance on eQMS processes. A Bachelor’s degree and GMP knowledge are preferred.

Qualifications

• Experience in a Document Control position within a Medical Device, Pharmaceutical, Biotech, or regulated company preferred.
• Understanding of Good Documentation Practices in regulated environments (ISO 13485/9001 and/or 21 CFR 820).
• Proficiency with MS Office and basic computer skills.

Responsibilities

• Process routine DCOs/PCOs per established procedures and escalate unusual requests.
• Draft, review, and approve templates, COAs, SDSs, and related docs to ensure GMP compliance.

Skills

Document control experience

Good Documentation Practices

MS Office

EDMS MasterControl

Education

Bachelor's degree

Tools

MasterControl

UNiPoint

Propel

Job description

Teknova in Hollister, CA seeks a Quality Systems Specialist I - Document Control to maintain change orders and support the QMS. You will review company-wide documents, manage records, and assist with audits and training.

The role involves drafting/reviewing templates and COAs, maintaining controlled docs, and providing guidance on eQMS processes. A Bachelor’s degree and GMP knowledge are preferred.