Senior QA Specialist - Regulatory & Process Excellence

BioSpace; Morrisville (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biotechnology company in North Carolina is looking for a Sr QA Specialist to enhance their Quality Management System. The ideal candidate will ensure compliance with regulations, support audits, and engage in continuous process improvement. Candidates should hold a relevant degree and have experience in quality assurance within a clinical or laboratory setting. This full-time position emphasizes strong communication and organizational skills.

Qualifications

• 0-3 years of prior experience in patient testing laboratory quality.
• Detail-oriented with excellent prioritization and organizational skills.
• Ability to multitask within specified timelines.

Responsibilities

• Assist in the operation and maintenance of the Quality Management System (QMS).
• Review and approve Non-Conformance reports and Quality Control records.
• Lead or support regulatory agency inspections.

Skills

Attention to Detail

Quality Assurance

Communication Skills

Regulatory Compliance Knowledge

Interpersonal Skills

Education

Bachelor's Degree in Science

Associate's Degree in Laboratory Science

Tools

MasterControl

Maximo

LIMS

Smartsheet

Job description

A leading biotechnology company in North Carolina is looking for a Sr QA Specialist to enhance their Quality Management System. The ideal candidate will ensure compliance with regulations, support audits, and engage in continuous process improvement. Candidates should hold a relevant degree and have experience in quality assurance within a clinical or laboratory setting. This full-time position emphasizes strong communication and organizational skills.