Kelly Science, Engineering, Technology & Telecom · 1 day ago
QC Analyst III
Kelly Science, Engineering, Technology & Telecom is seeking a Quality Control Analyst III to perform a variety of analytical and bioanalytical tests to support Quality Control operations. The role involves testing raw materials, in-process samples, and final products while ensuring compliance with cGMP/GxP requirements.
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
Qualification
Required
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
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.