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Quality Control Associate Scientist

HUVEPHARMA, INC

General Description: This position is responsible for supporting day-to-day operations within the Quality Control laboratory, with primary focus on in-process and final product testing. This position will also assist in the execution of laboratory protocols for product stability, method transfer, and reagent qualification studies. Qualifications: Associate degree in Microbiology, Biology, Immunology, or related life science required; Bachelor’s degree preferred 3-5 years (Bachelor’s degree) or 5-8 years (Associate degree) of technical experience in the pharmaceutical or related industry required Previous Quality Control or equivalent laboratory experience working in a USDA- or FDA-regulated environment preferred Knowledge and understanding of applicable USDA regulations and GMPs preferred Experience with aseptic technique preferred Excellent attention to detail Strong organizational and time management skills Excellent verbal, written, and electronic communication skills Competent computer skills utilizing Microsoft Office (e.g., Word, Excel, Outlook) and database management Knowledgeable about biosafety requirements and aseptic technique Job Responsibilities: Read and follow standard operating procedures and safety documents Handle biological agents and chemicals safely Effectively work independently and as part of a team Must adapt well to changing priorities Must consistently meet established timelines Perform concurrent documentation and maintain accurate laboratory notebooks to ensure compliance with regulatory requirements and company quality systems Assist with media/reagent preparation, laboratory cleaning, inventory maintenance, and daily equipment monitoring Assist with the calibration and maintenance of laboratory equipment Maintain mammalian cell cultures and/or perform growth promotion testing of media Perform in-process and final product testing in accordance with internal and external requirements, such as virus titration, bacterial enumeration, or sterility testing Under supervision, prepare and qualify new assay controls Under supervision, execute laboratory protocols Perform limited animal care and husbandry related to product testing Perform routine laboratory investigations, complete Corrective/Preventative Actions as assigned Effectively train and/or mentor laboratory personnel as assigned Review regulatory documents for accuracy and verify compliance with established procedures Recommend initiatives to improve processes, cost effectiveness, efficiency, safety, and compliance Effectively communicate with colleagues at all levels This position may require periodic weekend and/or holiday work #J-18808-Ljbffr

Vacancy posted 1 day ago
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