Clinical Quality Specialist Rochester Job Listing at Kelly Services in Rochester, NY (Job ID US3538302_BH9743601)

Description

Clinical Quality Specialist
Kelly® Science & Clinical is seeking a Clinical Quality Specialist for our client a leader in the medical device industry in Rochester, New York. 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.

Schedule: HYBRID- 2 days remotely - 3 days on site
Monday through Friday 8am to 5pm
Length of assignment: Until the end of 2025 possible extension into 2026
Pay: $30-35 an hour
Support the Clinical Quality Assurance function within Research and Development Operations with responsibility for managing audit program including audit schedules, audit records and CAPAs in the Quality Management Software, and conducting TMF audits ensuring clinical trials supporting pharmaceutical and medical device registrations are conducted incompliance with all applicable regulations.
Primary Responsibilities include

• Establishes, updates, and maintains annual audit schedule for GCP Vendors in the Quality Management Software (QMS).  Collects, reviews, and stores audit deliverables such as audit reports, audit response requests, CAPAs, and relevant audit support documentation in QMS.
• Maintains the GCP Vendor Approved Supplier List (ASL).
• Primary liaison with quality consultant auditors and auditing vendors. Coordinates auditors for clinical site, GCP vendor, and Trial Master File (TMF) audits.
• Liases with internal functional team members in Clinical Operations, Data Management, Statistics, Trial Master File, Clinical Trial Material, Clinical Development, and Clinical Quality Assurance to ensure preparation documentation is identified prior to audit. 
• Ensures new auditors complete and pass the qualification activities and stores evidence of qualification in Clinical Quality Assurance (CQA) SharePoint site.  
• Tracks audit deliverable timelines and ensures timely submission of audit documentation in accordance with Standards Operating Procedures.  Communicates and escalates risk audit timelines.  
•  Prepare folders in SharePoint for auditors with audit preparation documentation. 
• Develops and tracks vendor performance metrics to identify trends and mitigate emerging quality issues.
• Conducts TMF audits, once qualified.
• Contributes to or writes standard operating procedures.
• Performs gap assessments on current SOPs against emerging standards, regulations, and guidelines

Requirements

• Minimum BS/BA in related field.
• Working knowledge of Good Clinical Practice (GCP) regulations/guidelines (ICH E6 (R2) and (R3)); MDR 2017/745, ISO 14155:2020 (and 2024), FDA 21 CFR 50, 54, 56, 58, 312, 314, 812, 814, 820), and other applicable regulations, guidelines and standards for clinical research. 
• STRONG organizational skills required.
• Strong in Microsoft Word, Excel, and PowerPoint.
• Strong Microsoft TEAMS experience preferred.
• Strong attention to detail.
• Able to follow written and verbal directions and ultimately become independent in managing audit program.   
• Excellent communication required.  
• Experience with working with individuals from other countries/cultures a plus. 
• Ability to problem solve with critical thinking to troubleshoot issues. 

 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

 

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 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 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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