QC Analyst III

Quality Control Analyst III (Full-Time, Contract)

Location:

Winston-Salem, NC

Department:
Quality Control

Reports To:

QC Manager, Analytical

Positions: 2

Hourly Pay Rate: $35-$45

Schedule:

Sun-Thu 8:30a-5p shift and Tue-Sat 8:30a-5p

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.

• 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 in validations.
• 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.

• 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.

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.