Senior QA Auditor: GMP/GLP Compliance & Quality

MRIGLOBAL; North Kansas City (MO); On-site; USD 76,000 - 84,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Disability coverage

Gym reimbursement

PTO & holidays

Job summary

MRIGlobal, an independent scientific research organization headquartered in Kansas City, MO, seeks a Senior Quality Assurance Specialist to oversee GMP, GLP, and ISO 9001:2015 programs. You will audit facilities, review study reports, and manage deviations, CAPAs, and other quality events under senior QA guidance.

The role requires a BS in a related science, 3+ years in GxP QA or training, strong computing skills, and U.S. citizenship.

Qualifications

• Bachelor's degree in a science field and 3+ years in science, GxP QA, or training roles.
• Proficient with Microsoft Office applications.
• U.S. Citizenship is required.

Responsibilities

• Manages deviations, CAPAs, and other quality events.
• Performs quality audits of facilities, operations, documentation, and processes.
• Reviews and audits study reports for completeness and regulatory compliance.
• Evaluates responses to inspection or client audit reports and follows up until resolution.
• Inspects/audits equipment SOPs, maintenance, and calibration records.
• Establishes and maintains QA files and records per MRIGlobal requirements.
• Writes, reviews, and revises related policies, protocols, and procedures.
• May conduct staff training on quality and regulatory topics.

Skills

GxP quality assurance

Microsoft Office

Training experience

Education

Bachelor's degree in Chemistry, Biology, Engineering, or related science

Job description

MRIGlobal, an independent scientific research organization headquartered in Kansas City, MO, seeks a Senior Quality Assurance Specialist to oversee GMP, GLP, and ISO 9001:2015 programs. You will audit facilities, review study reports, and manage deviations, CAPAs, and other quality events under senior QA guidance.

The role requires a BS in a related science, 3+ years in GxP QA or training, strong computing skills, and U.S. citizenship.