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**Job Title:** Quality System Specialist

**Location** : Greendale IN- 100% Onsite

**Duration:** Temp to perm

**Pay Rate:** $30-$35/hr.

**Shift:** MON-FRI 8 HOURS A DAY STARTING AT 7, 8 OR 9AM.

Position Overview:

+ Our client is seeking a temporary Quality Management Systems Specialist to join our dynamic Quality Assurance team at our Greendale, Indiana site.

+ This role is critical to the integrity and continuous improvement of our site’s Quality Systems and will be responsible for supporting key compliance and quality system activities such as entry of Change Controls, Deviations, Complaints, and CAPAs into TrackWise.

+ The ideal candidate will bring an understanding of GMP principles, experience in pharmaceutical or dietary supplement manufacturing, and basic user knowledge of electronic quality systems (i.e. TrackWise or similar).

Responsibilities include, but are not limited to:

+ Quality Systems Oversight

+ Support site-level quality systems such as: Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.

+ Ensure timely and thorough completion of assigned documentation tasks.

+ Support cross-functional teams quality system updates.

Computerized System Compliance

+ Support Data Integrity initiatives for electronic systems including TrackWise, EDMS, and other validated platforms.

+ Participate in system upgrades, validation activities, and periodic reviews to ensure ongoing compliance.

Documentation & Audit Support

+ Collaborate with Document Control and QA teams to ensure controlled documents are accurate, current, and compliant.

+ Support internal, client, and regulatory audits by preparing documentation as assigned.

+ Assist in batch record review/filing, complaint investigation initiation, and audit readiness activities as needed.

Skills, Experience, Qualifications:

Required:

+ 2+ years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement preferred).

+ Experience with 21 CFR 111, 21 CFR 211, or 21 CFR 11.

+ Working knowledge of Quality Systems and Quality Assurance

+ Experience with Microsoft Office Suite.

+ Excellent written and verbal communication skills.

+ Strong organizational and time management abilities.Preferred:

+ Experience with TrackWise and/or EDMS or equivalent

+ Lean Six Sigma or similar continuous improvement training

+ Project Management

Why Kelly?

Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*

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.