Senior QA Specialist: ISO/FDA Compliance & Audit Leader

Bio-techne; Newark (CA); On-site; USD 89,000 - 147,000; Full time

Benefits offered by this job

Medical, dental, vision, life

401k and ESPP

Mentorship and career development

Job summary

Bio-Techne is seeking a Sr. Quality Assurance Specialist to ensure quality processes are compliant with ISO 13485 and FDA QSR. You will lead document control, internal audits, CAPA activities, and regulatory reporting while supporting batch record review and material disposition in a laboratory environment.

The role requires 3+ years in QA, strong communication, and experience with nonconformances and CAPA processes. Onsite work in a lab setting with comprehensive benefits is offered.

Qualifications

• BS/BA in science, engineering or related field required.

Responsibilities

• Document Control activities and maintain electronic database.
• Conduct internal audits and prepare audit reports.
• Review nonconformances and CAPAs; participate in MRB/CAR meetings.
• Assist with batch record review and material disposition.

Skills

Document Control

Internal Audits

CAPA

FDA QSR/ISO13485 knowledge

Excel data analysis

Verbal & written communication

Lead Auditor

Education

BS/BA in science or engineering

QA-related certifications (ASQ CQE/CQA)

Tools

Microsoft Office

Job description

Bio-Techne is seeking a Sr. Quality Assurance Specialist to ensure quality processes are compliant with ISO 13485 and FDA QSR. You will lead document control, internal audits, CAPA activities, and regulatory reporting while supporting batch record review and material disposition in a laboratory environment.

The role requires 3+ years in QA, strong communication, and experience with nonconformances and CAPA processes. Onsite work in a lab setting with comprehensive benefits is offered.