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Quality Control Analyst
Lincoln, NE

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Huvepharma

Quality Control Associate Scientist

Job Description

Position Description The Quality Control Associate Scientist will contribute to the development, licensing, production, and testing of animal health vaccines. This position is responsible for supporting day-to-day operations within the QC 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 Education/Experience Requirements 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 Technical Skill Requirements 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 Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May require lifting 50 lbs. or less; the position requires sitting or standing for extended periods of time, as well as the performance of repetitive motions. Ability to travel, not to exceed 5% Position 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 will require periodic weekend and holiday work
Competencies:
Communication Customer Focus Integrity, Safety & Compliance Collaboration Achieves Results Job Type:
Full-time Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Referral program Vision insurance
Work Location:
In person