Compliance Engineer

• Industry : Pharmaceutical industry or medical device experience required

• Location: Onsite - Round Lake, Illinois (60073)

• Type: Contract - (NO C2C OR THIRD PARTY)

• Duration: 6+ months - Opportunity for contract extension long term

• Pay Rate – Negotiable depending on DIRECT-related experience

• Work Authorization - Must be able to work in the U.S. with approved authorization status as a citizen or lawful permanent resident of the United States. Visa Status is not allowed for this role as current or future sponsorship is unavailable.

• This role is NOT a validation engineering role

Candidates cannot be allergic to Penicillin or Cephalosporins.

Preferred:

• Project management experience

• Experience with due diligence, auditing, compliance management, or regulatory experience

• Hands-on experience in drug product aseptic manufacturing operations

JOB SUMMARY:

• Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System.

• Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines, and compendia as requirements.

RESPONSIBILITIES:

• Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.

• Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.

• Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness.

• Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility

Qualifications:

• Experience with pharmaceutical and/or device quality and compliance management systems

• Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.

• Knowledge of Six Sigma methodology and LEAN principles.

Education and Experience:

• • At least 5 years of directly related experience within the pharmaceutical industry or medical device experience

• • BS in Science or Engineering. Advanced degree a plus.

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.

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 ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

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 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.

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.