Senior QA Specialist - Lead Auditor & Compliance Expert

Advanced Cell Diagnostics, Inc.; Newark (CA); On-site; USD 89,000 - 147,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) and ESPP

Health Savings Account (HSA)

FSA and dependent care

Tuition reimbursement

Employee resource groups

Paid holidays and PTO

Job summary

Bio-Techne is seeking a Quality Assurance Specialist to ensure that quality requirements are met and to support continuous improvement. The role involves document control, internal audits, CAPA management, and validation activities to uphold ISO 13485 and FDA Quality System requirements.

Strong communication, analytical, and organizational skills are required, with a background in a related science or engineering field and at least 3 years in QA.

Qualifications

• Strong QA experience in a regulated environment.

Responsibilities

• Document control activities in an electronic database.
• Conduct internal audits per plan.
• Prepare audit reports and findings.
• Assist with batch record review and release.
• Review nonconformances and CAPAs.
• Prepare and host CAPA Review Board meetings.
• Monitor QA indicators for management reviews.
• Write validation plans and reports.
• Execute validations.
• Edit QA SOPs and procedures.
• Support other QA duties as needed by QA management.

Skills

Document Control

QA regulations

Verbal & written comms

Lead auditor

CAPA processes

Microsoft Excel

Education

B.S. in a related science/engineering

Tools

Electronic database

Microsoft Excel

Word

PowerPoint

Job description

Bio-Techne is seeking a Quality Assurance Specialist to ensure that quality requirements are met and to support continuous improvement. The role involves document control, internal audits, CAPA management, and validation activities to uphold ISO 13485 and FDA Quality System requirements.

Strong communication, analytical, and organizational skills are required, with a background in a related science or engineering field and at least 3 years in QA.