Scientist I, Production

Reports To: Manager, Operations

Position Location: North Charleston, SC 

FLSA Status (Exempt/Non-Exempt): Non-Exempt 

Position Summary: 

Individuals serving in this position will be working in manufacturing, product development, and Quality testing at the Diagnostics business units. Employees will be trained in a variety of lab techniques specific to the department assigned as well as document generation and completion. The incumbent must be a dynamic individual who can multi-task and perform various activities associated with manufacturing operations while adhering to all safety policies and high quality Standard Operating Procedures. This position requires hands on lab work and will report to the Lab or Production Manager.  

Key Responsibilities: 

• Execution of quality system procedures 
• Proper execution of SOPs, safety guidelines, and work instructions for manufacturing procedures assigned by supervisor 
• Ability to work individually as well as part of a team towards completion of specific projects 
• Use of manufacturing related equipment as required by work instructions and SOPs 
• Data analysis 
• Demonstration of sound problem-solving skills and troubleshooting abilities 
• Communicate exceptions to established/agreed upon schedules to all affected parities internal and external. 
• Adherence to quality systems with special regard to FDA, ISO 13485 and GMP / OSHA compliance 
• QC testing of components and finished products including organization of inventory, weighing actual hands-on inventory, and updating systems. 
• Inventory management of materials and supplies 
• Focus on continual process improvement 
• Cleaning and maintenance of equipment 
• Guided experimental design and product testing assigned by supervisor 
• Preparation of reagents, media, and buffers 
• Performs other duties as assigned

Department Specific Potential Duties:

• Assist and manufacture inorganic or organic products using knowledge of chemistry principles. 
• Experience with general chemistry glassware, lab supplies and concentrated acid handling 
• Experience with hot block digestion, auto pipettes, and sample preparation preferred. 
• Basic mathematics and familiarity with general chemistry calculations 

Experience: 

• 4-year B.S. degree required in biology, microbiology, chemistry, or other life sciences program
• Relevant experience in laboratory skills/cGMP preferred. Including but not limited to pipetting, preparing reagents, centrifugation, recording observations, etc. 

Minimum Requirements/Qualifications: 

• Ability to analyze and interpret data and results
• Proficiency in Microsoft Office 
• Strong analytical, problem solving, process improvement skills 
• Attention to detail 
• Ability to multitask and adapt to changing priorities 
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines  or other time essential constraints 
• Excellent communication skills, both written and verbal, to communicate to all levels of the organization clearly and concisely 
• Strong work ethic and an ability to excel within a rapidly changing and growing organization 
• Willingness to cross train and support other teams as needed for our medium sized business. 

Physical Requirements/Working Conditions: 

• Potential Hazards: solvents, acids, bases, infectious organisms, carcinogens, combustibles, fast paced environment, repetitive motion, 
• Recommended PPE: Closed toe shoes, lab coats, gloves, safety goggles, Tyvek suits in level three biohazard laboratories