Assistant/ Associate Biologist

Grifols•Clayton, NC

11d•Onsite

About The Position

The incumbent is responsible for performing complex laboratory analysis of plasma and plasma products in a GMP laboratory. Responsibilities include sample accessioning, sample preparation, reagent preparation, testing, result calculation, as well as quality control of assays and equipment. The incumbent will also support assay validation, method transfer, reagent and control qualification, and laboratory maintenance activities as assigned. Must be comfortable working with infectious material on a daily bases. Person must be able to work in a biological safety cabinet and comfortable working with a microscope for several hours at a time. Candidates for the position must be proficient with using micropipettes and serological pipettes while making dilutions and serial dilutions. The person that fills this position must possess a keen attention to detail in that they will be performing complex tissue culture assays and maintaining cell lines. Tissue culture is preferred. Must be able to perform tasks by following SOP’s and oral instructions. Must have precise, legible, and organized documentation skills. Candidates must also being willing to perform ones share of cleaning duties and housekeeping. This position is responsible for performing environmental monitoring of fill lines in B300 and SFF and also environmental monitoring of all classified production areas, including sampling of site utility systems. Environmental Assurance department must maintain adequate staffing to support all filling operations 24 hours per day, 7 days a week. In addition to routine environmental monitoring of the aseptic fill lines, this position is also responsible for executing the Quality Oversight program for the fill lines and also provides quality control approval of air flow visualizations conducted on site. This position is part of the budgeted staff necessary to complete this sampling and testing and to ensure that Clayton site environmental monitoring of the aseptic fill lines and other production areas and utility systems remain in a state of control. Current production levels require that multiple filling activities can occur during any shift and require EM staff to be available to support these activities in order to avoid production delays.

Requirements

Proficiency with using micropipettes and serological pipettes while making dilutions and serial dilutions.
Keen attention to detail.
Ability to perform tasks by following SOP’s and oral instructions.
Precise, legible, and organized documentation skills.
Willingness to perform cleaning duties and housekeeping.
Assistant level: AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 6-12 months of applicable laboratory experience.
Associate level: AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 2 years of applicable laboratory experience.
Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye.
Ability to communicate complex information and ideas so others will understand.
Ability to listen to and understand information and ideas presented through spoken and written words and sentences.

Nice To Haves

Tissue culture experience is preferred.
Background in medical technology / clinical laboratory science is preferred.
Experience in a GLP / GMP laboratory is preferred.

Responsibilities

Performing complex laboratory analysis of plasma and plasma products in a GMP laboratory.
Sample accessioning, sample preparation, reagent preparation, testing, result calculation, and quality control of assays and equipment.
Supporting assay validation, method transfer, reagent and control qualification, and laboratory maintenance activities.
Working with infectious material on a daily basis.
Working in a biological safety cabinet and with a microscope for several hours at a time.
Using micropipettes and serological pipettes while making dilutions and serial dilutions.
Performing complex tissue culture assays and maintaining cell lines.
Performing tasks by following SOP’s and oral instructions.
Performing environmental monitoring of fill lines in B300 and SFF.
Performing environmental monitoring of all classified production areas, including sampling of site utility systems.
Executing the Quality Oversight program for the fill lines.
Providing quality control approval of air flow visualizations conducted on site.
Performing cleaning duties and housekeeping.