Scientist I, Production

Job Description

Job Description

Job Title : Scientist, Production

Reports To : Lab, Production, or Quality Supervisor

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 :

Chemistry

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

This position has not been approved for Relocation Assistance.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.