Senior QA Specialist

MRIGLOBAL; North Kansas City (MO); Sur place; USD 76 000 - 84 000; Plein temps

Avantages offerts par ce poste

Health insurance

Life insurance

Disability coverage

Gym reimbursement

PTO & holidays

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GxP quality assurance

Microsoft Office

Training experience

Formation

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

Description du poste

Are you passionate about making the world better? Are you looking for an organization that aligns with your values?

MRIGlobal solves challenging problems through science, engineering, and program management. We are an independent scientific research organization dedicated to benefiting society and fostering a safe, healthy, and sustainable environment.

When you embark on a career with MRIGlobal, you are joining a crew of world-class talent and problem solvers. Established in 1944, MRIGlobal is headquartered in Kansas City, MO, working in several states including Virginia and Maryland.

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.
• Perform 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

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

Pay Range - $75,500 - $84,000

The salary range is intended as a general guideline and is not a guaranteed offer, as compensation depends on various factors such as scope and responsibilities of the position, candidate qualifications, experience, internal equity, and market conditions. MRIGlobal also provides a comprehensive benefits package, including health and life insurance, disability coverage, gym reimbursement, mental health support, paid holidays, and PTO.

WHAT WE OFFER At MRIGlobal, we offer benefits and perks that make your life even better.

Your Well-Being: You can receive comprehensive coverage for you and your family, and resources that support mental, physical, social, and financial well-being. Get access to wellness benefits like virtual coaching, no-cost counseling, onsite health screenings, gym reimbursement, and more. MRIGlobal has received multiple wellness recognitions, including being named "Healthiest Employer" by Kansas City's Business Journal in 2024.

A Bright Future: MRIGlobal offers award-winning employer retirement matches and no-cost financial education benefits. Get paid Parental Leave. Enjoy PTO, and a flexible culture that encourages work-life integration.

Personal Development: At MRIGlobal, you will enjoy diverse work that will grow your skillset, along with a tuition reimbursement option to pay for higher education.

A Genuine Community: MRIGlobal is a special workplace. From our Chili Cook-offs, Pi Day, and charitable giving opportunities, our traditions strengthen our team spirit. Join our seasonal staff events, DEI celebrations, and volunteer in initiatives that nurture future STEM generations.

EOE, including disability/vets. As an organization dedicated to scientific advancement, MRIGlobal invites and embraces diversity in our people. We value their unique backgrounds and perspectives in every aspect of our mission. We are committed to creating a safe, welcoming, and inclusive environment where everyone feels respected and represented, fostering a culture where all input is welcome. We adapt to change, challenge the status quo, and evolve through belonging, allyship, and mutual support.

Certain roles, depending on the nature of the job or work assignment require adherence to specific safety measures, including up-to-date vaccinations. This requirement aligns with both our operational needs and the expectations of our clients. Employees must furnish proof of such vaccinations before commencing their duties. Should an individual be unable to meet this vaccination criterion due to a legitimate medical condition, disability, pregnancy, or religious belief, we offer the option to apply for a reasonable accommodation in line with applicable laws. Inquiries or requests for accommodations should be directed to [e-mail], ensuring a prompt and considerate resolution process. It's important to note that failure to comply with a vaccination-required role or to secure an approved accommodation may affect one's employment status with our organization.