"Alerted.org

Quality & Regulatory Specialist

Nashville, TN

Remote/Hybrid

The Quality & Regulatory Specialist plays a crucial role in maintaining the integrity of the Company’s proprietary diagnostic tests. Reporting to the Sr. Director, Quality and Regulatory, this position is responsible for overseeing and managing quality and regulatory processes and documentation. Key areas of focus include document control, training, and providing comprehensive quality and regulatory support for both operations and pharma services.

Job Responsibilities:

+ Lead activities related to the following:

+ Change Management

+ Document Control

+ Records Management

+ Training: Assist Managers with creating and maintaining training plans and records.

+ Management Review

+ Assist in the development and implementation of inspection readiness and support senior staff during regulatory inspections or other audits.

+ Promote awareness of applicable regulatory requirements, including QMS requirements and customer requirements throughout the organization.

+ Assist in the execution of efficiency improvement projects and other administrative tasks for the department and company, as needed.

+ Participate in all QA & RA programs, procedures, and controls to ensure product processes conform to established standards and agency guidelines.

+ Perform other tasks as assigned.

Lead Activities for Regulatory Processes:

+ MLR Document Approval

+ External Standards

+ Assist with submission projects in conjunction with contributing departments.

+ Assist with other regulatory activities and submission publishing as needed.

Coordinate Activities for Quality Processes:

+ Supplier Quality

+ Corrective and Preventive Actions (CAPA)

+ Internal Audits

Participate/Assist in Quality and Regulatory Processes:

+ Risk Management

+ Complaint Investigations

+ Regulatory Documentation

eQMS System Management:

+ Lead the development and implementation of the eQMS system.

+ Manage software requirements and configuration based on company needs and quality/regulatory requirements.

+ Collaborate with project managers and departmental leads to evaluate new solutions, upgrades, and add-on tools.

+ Solve user challenges related to documents, provide templates, and correct user errors.

+ Create accounts for all new hires and terminations.

+ Ensure all new hires complete required onboarding training.

Job Qualifications:

+ Bachelor’s degree or equivalent experience.

+ 2 years of QMS experience working in a regulated, GMP environment/industry.

+ At least 3 years of quality assurance, regulatory, and/or compliance experience within a regulated industry.

+ Experience using Master Control software is preferred.

+ Document review experience is required.

+ Strong writing skills, with the ability to present findings in a clear and concise manner.

+ Proficient in Excel, demonstrating competency in creating graphs, metrics, and trending using Excel functions.

+ Experience with eQMS / ERP systems is preferred.

Job Details:

+ Work Schedule: M-F; 8am-5pm (Subject to Change)

+ Temp-to-Hire

+ Remote/Hybrid

+ Medical Insurance, Health Plan, Dental, Vision, Whole Life Insurance, Term Life Insurance, Short Term Disability, Accident Insurance

If you're ready to bring your quality & regulatory expertise to a role where your work truly matters, we want to hear from you!

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.