Quality Specialist, Compliance & Supplier Quality Job Listing at Kelly Services in Rochester, MI (Job ID US3551586_BH9785052)

Description

Quality Specialist, Compliance and Supplier Quality
Kelly® Science & Clinical is seeking a Quality Specialist, Compliance and Supplier Quality for a global pharmaceutical manufacturing client based in Rochester MI. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Length of assignment: 6mo contract with enhanced benefits, potential to extend
Location: Rochester MI
Schedule: Monday-Friday, 1st shift
Compensation: $65,000-75,000/yr

Responsibilities:
Compliance:

• Ensure compliance with relevant regulations, including Good Manufacturing Practices (GMP) and other industry standards. 
• Review and approve GMP clinical packaging batch records and executed clinical packaging records. 
• Follow up on deviations and quality incident investigations, resolving and tracking deviations and CAPAs. 
• Assess risk levels associated with non-conforming items and escalate to management. 
• Monitor and track CAPA and complaints, analyze data, and prepare reports. 

Supplier Quality:

• Provide quality oversight to supplier qualifications and materials qualification. 
• Partner with Global Quality and counterparts from other sites for third-party management. 
• Establish and maintain quality technical agreements with third parties. 
• Analyze supplier processes and planning to verify compliance. 
• Visit suppliers and perform root cause analysis to drive improvements. 
• Manage supplier ratings/scorecard systems. 
• Participate in Early Supplier Engagements. 

Quality Systems:

• Manage Quality Systems at the site and potentially assist other sites with metrics. 
• Monitor, track, and trend CAPA and complaints. 
• Ensure interpretation and consistency with compliance guidance provided. 

Other:

• For Clinical Packaging, act as the primary Quality contact for Clinical Supply labeling, packaging and distribution. 
• Support Due Diligence activities, as requested. 
• Provide Good Clinical Practices (GCP) guidance to workgroups and to business partners. 
• Assist in the facilitation of inspections by regulatory authorities for GCP

 
Qualifications

• Bachelor's degree required, preferably in pharmaceutical discipline or technical field
• 3+ years of experience in pharmaceutical/biological manufacturing, packaging, and laboratory operations
• Deep understanding of cGMP regulations and quality principles within the pharmaceutical industry.

What happens next?
Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry—even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more. Helping you discover what's next in your career is what we're all about.

#P1

Please send resumes to Jacqueline.Sayoc@KellyScientific.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 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.

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