QC Analyst

Quality Control Analyst (Full-Time, Contract)

Location: Winston-Salem, NC

Department: Quality Control

Reports To: QC Manager, Analytical

Position Summary

The Quality Control Analyst is responsible for performing a variety of analytical and bioanalytical tests to support Quality Control operations. This role includes testing of raw materials, in-process samples, stability samples, and final product. The analyst will maintain accurate data, support investigations, ensure compliance with cGMP/GxP requirements, and contribute to continuous improvement within the QC laboratory.

This is a contract position and does not include company-sponsored benefits.

Key Responsibilities

• Perform routine bioanalytical testing and support release of in-process, stability, and final product samples.
• Conduct routine and non-routine analyses on raw materials, in-process items, and finished products using established procedures, including:
• Flow cytometry
• ELISA
• Kinetic assays
• Cell counting/viability
• Visual inspections
• Initiate and support deviation and OOS investigations within electronic quality systems.
• Support completion of action items and AQEM activities in the quality system.
• Follow test methods, SOPs, work instructions, and protocols accurately.
• Author or revise test methods, SOPs, work instructions, forms, and protocols as needed.
• Assist with sample receipt and coordination with manufacturing.
• Train and mentor incoming QC Analysts across all levels.
• Track and trend QC testing performance, including patient lot data and critical reagent monitoring.
• Maintain lab inventory and coordinate material requests with warehouse/supply chain teams.
• Participate in change control activities and document assay failures or invalidations.
• Ensure all documentation is completed accurately and on time.
• Support special projects related to analytical method development or instrumentation troubleshooting.
• Perform additional duties as assigned.
  

Minimum Qualifications

• Bachelor’s degree in chemistry, biochemistry, microbiology, or related scientific field.
• 3–5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacturing, or medical device industry.
• Strong understanding of cGMP, GxP, and FDA regulations.
• Familiarity with bioassays and raw material testing methods.
• Experience with LIMS or other electronic quality/data systems.
• Experience with deviation handling, change control, and OOS investigations.
• Subject matter expertise in relevant analytical assays.
• Strong communication skills and ability to work cross-functionally.
• Excellent attention to detail, problem-solving skills, and decision-making ability.
  
  

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.