Laboratory Analyst

Bionique Testing Laboratories • Saranac Lake, NY

235d • $21

About The Position

This position will perform routine mycoplasma testing (cell-based and/or molecular biology assays) of manufactured in-process, commercial and clinical products according to CGMP regulations and associated standard operating procedures. Training and duties will include performance of procedures and operations directly relating to mycoplasma protocols in compliance with CGMP standards. These may include but are not limited to aseptic technique, direct culture procedures, subculture procedures, microscopy, DNA extraction, real-time PCR, media preparation, record keeping, and laboratory maintenance activities.

Requirements

• BS/BA in cell biology, microbiology, biochemistry, or related scientific field highly preferred
• Equivalent combination of education, training and experience may be substituted
• Laboratory experience working in CGMP microbiology or cell culture lab, or experience in a regulated environment is preferred
• Knowledge and experience with aseptic techniques desirable
• Team-oriented individual with excellent communication skills
• Must be able to pay attention to details
• Enthusiasm for learning and contributing to improved patient outcomes
• Ability to work weekends on a rotating basis

Responsibilities

• Prepare, inoculate (using aseptic technique), and monitor broth and agar cultures and evaluate them for mycoplasma growth
• Perform fluorescent microscopy to identify mycoplasma growth in mammalian cell cultures
• Maintain mammalian cell cultures
• Perform DNA extractions and real-time PCR analysis to test for the presence of mycoplasma DNA
• Perform routine monitoring, maintenance, and cleaning of instruments and equipment
• Prepare and maintain required frozen stock mycoplasma control organisms
• Document all laboratory activities accurately and completely
• Drive performance improvement experiments
• Assist with Quality Control and Quality Assurance activities
• Ensure proper level of laboratory supplies and reagents
• Maintain laboratory in an audit readiness stage and CGMP compliant manner at all times
• Review data for conformance to CGMP specifications and assist with investigation of laboratory deviations
• Troubleshoot as needed
• Generate data and reports as requested
• Assist in data trending and data review, investigations, as well as participate in non-routine R D projects
• Responsible for collecting and entering data from electronic systems
• Contribute to creating and revising standard operation procedures
• Ensure quality and safety of testing operations. Follow established safety and environmental guidelines and procedures for all work performed
• Performs jobs responsibilities as directed and completes tasks as assigned
• Keeps manager informed of progress and communicates effectively with colleagues as necessary to achieve assigned tasks and goals
• Ability to adhere to a standard timeline and escalate actions appropriately for resolution in a timely manner

Benefits

• Comprehensive benefits package
• Growth opportunities throughout the companies
• Diverse environment to enhance your career

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree