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Scope of Position:
In this role, you will be responsible for quality control testing of products to support manufacturing, engineering, and development. You will need to adapt and develop the test methods used for product evaluations and will be involved with organizational health and safety management systems, procedures, and programs. The role encompasses the application of scientific and technological principles concerned with the integrity of manufactured products and processes from an engineering standpoint, testing procedures, and minimum quality standards. You will use the principles and theories of science, engineering, and mathematics to provide technical support in a quality control laboratory, department, or process control group.
You will conduct standardized laboratory tests and routine experiments requiring the use of well-established procedures and prepare reports and recommend solutions to technical problems as required. We look for you to work on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations. You should expect limited instruction on routine work and general instructions on new assignments.

Day to Day Responsibilities:
• Responsible for maintaining lab equipment, which may require scheduling service or repairs with equipment vendors.
• Troubleshoot equipment and Bioassays as needed.
• Maintains a clean and safe work area.
• Follows GMP and ISO regulations and policies and procedures.
• Evaluate products returned for performance using established and newly developed testing methods.
• Assist customer through Technical Services in the process of resolving technical issues.
• Validate new Bioassay products/processes and develop new and appropriate test methods for evaluating these new products and/or processes.
• Fix production problems associated with Bioassay products using established and innovative testing techniques.
• Keep precise and timely records of experimental procedures and testing processes.
• Write and maintain current the procedures for the QA tests performed on Bioassay products. Write and maintain current all procedures used for product validations.
• This position will also be responsible for endotoxin testing and will assist in environmental monitoring activities.

Travel Requirements:
• Less 10% domestic as needed.

Hours of work/work schedule/flex-time:
• M-F, flex start/end time, first shift.

Required Education:
• High School Diploma or GED required.

Required Years and Area of Experience:
• Minimum 1+ years’ experience with bioassays (ELISA) within the life science/pharma industry.
• Ability to solve issues are critical for this position.
• Proficiency in Microsoft Word and Excel.

Desired:
• Bachelor’s degree in a science related field preferred.
• Experience quality and quantity performance standards under normal supervision.
• Familiarity with cGMP environments and QC testing methodologies (e.g. pH, osmolality, density, endotoxin, sterility, cell culture, and microbiological methods).
• Prior experience performing testing and track record of delivering results.

Soft Skills:
• Do you focus on getting the details correct?
• Are you able to work well both independently and in a group setting?
• Do you have effective written and verbal skills?
• Do you possess the ability to handle multiple tasks concurrently timely?
• Ability to display eagerness to learn and continuously improve.
• Positive work attitude that supports collaboration and continuous improvement.