Senior QA Specialist

Basic Function/Nature and Scope
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.
Essential Functions

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.

Success Factors

Promotes a mindset of quality and continual process improvement.
Knowledge of a broad range of technical disciplines

Applies knowledge across multiple interdisciplinary fields.

Organizes and prioritizes work effectively while maintaining close attention to detail.

Ability to work independently and in a team environment across organizational lines
Ability to wear personal protective equipment during audits if necessary

Proficient in Microsoft business applications and able to learn new software.
Communicates complex concepts clearly in writing and orally and represents MRIGlobal professionally in interactions with staff, clients, and regulatory agency personnel.

Minimum Qualifications

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.

Preferred Qualifications

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.