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

• 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.
• Able to work independently and in a team environment across organizational lines.
• Able 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.

Pay Range

$75,500 - $84,000

Benefits

• Comprehensive coverage for you and your family, and resources that support mental, physical, social, and financial well-being.
• Virtual coaching, no-cost counseling, onsite health screenings, gym reimbursement.
• Award-winning employer retirement matches and no-cost financial education benefits.
• Paid Parental Leave.
• Paid holidays and PTO.
• A flexible culture that encourages work-life integration.
• Diverse work that will grow your skillset, along with a tuition reimbursement option to pay for higher education.
• Charitable giving opportunities and volunteer initiatives that nurture future STEM generations.

What We Offer

• Your Well-Being: Comprehensive coverage for you and your family, and resources that support mental, physical, social, and financial well-being.
• Personal Development: Diverse work that will grow your skillset, along with a tuition reimbursement option to pay for higher education.
• A Bright Future: Award-winning employer retirement matches and no-cost financial education benefits.
• Personal Development: Diverse work that will grow your skillset, along with a tuition reimbursement option to pay for higher education.
• A Bright Future: Paid Parental Leave, PTO, and a flexible culture that encourages work-life integration.
• Personal Development: Diverse work that will grow your skillset, along with a tuition reimbursement option to pay for higher education.
• A Bright Future: Tuition reimbursement option to pay for higher education.
• Personal Development: Diverse work that will grow your skillset, along with a tuition reimbursement option to pay for higher education.
• A Bright Future: Tuition reimbursement option to pay for higher education.

Equal Opportunity Employer

MRIGlobal is an equal opportunity employer, including disability/vets.