Quality control analyst jobs in High Point, NC - 99 jobs

**Quality Control Analyst III (Full-Time, Contract)** **Department: Quality Control** **Reports To: QC Manager, Analytical** **2 positions** **Hourly Pay Rate: $35-$45** **Schedule: Sun-Thu 8:30a-5p shift and Tue-Sat 8:30a-5p** **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. 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