QC Associate II-ON SITE

Our client is currently seeking a QC Associate II-ON SITE J ob Duties Execute QC molecular biology and Bioassay methods (e.g. Mammalian cell based potency, qPCR, sequencing, protein analysis) The Quality Control Associate II will support cGMP QC testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers, qualification activities, and ensuring compliance with cGMP standards. This is an on-site position. Job Duties Execute QC molecular biology and Bioassay methods (e.g. Mammalian cell-based potency, qPCR, sequencing, protein analysis) Assist in troubleshooting equipment and assay issues. Perform general laboratory support activities including reagent preparation, equipment maintenance, housekeeping, logbook reviews, etc. Establish and maintain a safe laboratory working environment. Write, revise, and maintain SOPs, protocols, and reports. Support training as assigned. Assist in execution of Quality records (i.e. investigations, change controls, CAPAs) Ensure compliance with cGMP documentation and regulatory guidelines. Accountable for all mandatory training and assigned tasks. Provide support during audits and collaborate on continuous improvement initiatives. Additional duties may be assigned. Job Requirements Education: BA/BS Degree Experience: STEM degree with 3-5 years' of experience in a cGMP laboratory setting, with hands-on experience in mammalian cell culture, cell based and potency assays, ELISA, molecular biology, and Protein Analysis. Specific Certifications or Training: None Preferred Qualifications Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods. Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes) Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet Experience with laboratory equipment calibration and maintenance. Ability to work effectively in a fast-paced, cross-functional matrix environment. Familiarity with relevant FDA, EU, ICH guidelines, and regulation Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements. The Judge Group