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Job Title: eQMS Implementation Specialist

Department: Quality Assurance

**Location:** Somerset NJ

Position Summary:

The **eQMS Implementation Specialist** will support the Quality department in the **planning, implementation, validation, and rollout** of computerized quality management systems (eQMS). The Specialist will gain hands-on experience in deploying quality systems in a **regulated cGMP environment** , while contributing to continuous improvement efforts to enhance compliance, efficiency, and data integrity.

Key Responsibilities:

+ Assist in developing and documenting **User Requirements Specifications (URS), Functional Specifications (FS),** and **Validation Protocols (IQ/OQ/PQ)** .

+ Participate in and document **system validation activities** , including authoring and executing PQ scripts.

+ Coordinate and document **meetings, action items, and project timelines** with cross-functional teams.

+ Support the **migration from legacy systems to new platforms** , ensuring complete and accurate documentation throughout all project phases.

+ Organize and review system-related documentation for quality and regulatory alignment. Lead or assist with **user training coordination** and gather feedback for continuous improvement.

+ Author and revise **Standard Operating Procedures (SOPs)** and **Work Instructions (WIs)** approximately 50% of the time will involve technical writing from scratch.

+ Perform **workflow and form configuration** within the eQMS platform based on evolving business needs.

+ Collaborate with IT, QA, and business stakeholders during system go-live and post-implementation support.

+ Participate in **risk assessments** and **impact analysis** for system changes.

+ Ensure alignment with global regulatory expectations for electronic systems (e.g., **21 CFR Part 11** , **EU Annex 11** ).

+ Uphold data integrity principles and maintain compliance with **cGMP** and company policies. Adhere to all **Environmental, Health, and Safety (EHS)** responsibilities.

Qualifications:

Education & Experience:

+ Bachelor’s degree in a scientific, engineering, or information technology field.

+ Minimum **3+ years of experience** in the **pharmaceutical or biotech industry** , particularly within a cGMP-compliant environment.

+ Hands-on experience with **technical writing, documentation control, and QA/regulatory compliance** .

+ Familiarity with **Computerized System Validation (CSV)** methodologies and lifecycle documentation.

+ Experience writing and executing **PQ scripts** and contributing to validation reports.

+ Proficient in authoring SOPs and system-related documentation from scratch.

Preferred Tools/Systems Experience:

+ Exposure to systems such as **MasterControl, TrackWise, ComplianceWire** , or other eQMS platforms.

+ Experience in **system migration** and managing documentation during system transitions is highly desirable.

Key Competencies:

+ Strong **technical writing** and document management skills.

+ Detail-oriented with a commitment to **data integrity and regulatory compliance** .

+ Solid understanding of **GMP** , **QA** , and **regulatory standards** for computerized systems.

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.