Quality Control Associate Scientist

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.

• 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

• 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