Senior QA Specialist

MRI Global • North Kansas City, MO

3d

About The Position

The Senior Quality Assurance Specialist provides quality input and oversight for GMP, GLP, and ISO 9001:2015 programs and projects under the direction of senior QA staff or management. The position audits programs, facilities, and documentation to verify compliance with applicable regulatory and MRIGlobal requirements; maintains required quality documentation; supports Principal Specialists, QA management, and other areas of the QA program; assists with client audits; and provides technical expertise to resolve compliance issues. The specialist may also support other MRIGlobal facilities, conduct follow-up or subcontractor audits, and assess readiness to meet client requirements. Responsibilities are performed independently and require knowledge of applicable regulations and internal processes and procedures.

Requirements

• Bachelor's degree (B.S./B.A.) in Chemistry, Biology, Engineering, or related science from a four-year university or college.
• At least three years of experience in science, GxP quality assurance, and/or training roles, or an equivalent combination of education and experience.
• Excellent computer skills including familiarity with Microsoft business applications.
• U. S. Citizenship is required.

Nice To Haves

• Direct experience in a CRO, CDMO, commercial pharmaceutical, medical device, or other relevant GxP quality assurance role.
• Ability to manage diverse responsibilities in a fast-paced, highly complex organization.

Responsibilities

• Manages and follows up on deviations, CAPAs, and other quality events.
• Performs quality audits of laboratory facilities, operations, documentation, and processes; documents findings; and reports results to management.
• Reviews and audits study reports to verify that they are complete, accurate, supported by the raw data in the study file, and compliant with applicable regulatory requirements.
• Evaluates responses to inspection and client audit reports and performs follow-up with respondents, management, or others, as needed, through resolution.
• Inspects/audits equipment SOPs, maintenance, and calibration records.
• Establishes and maintains QA files and records in compliance with applicable regulatory and MRIGlobal requirements
• Writes, reviews, and revises quality related policies, protocols, and procedures.
• May conduct training sessions for staff on quality and/or regulatory topics
• Performs other tasks and duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior