Quality Control Analyst I
The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples. The Analyst works independently on assays that he/she has mastered.
The Analyst will be responsible for performing, under direct or minimal supervision, sample testing compliant with cGMP guidelines to meet specified timelines. This position required willingness to undergo training on more advanced analytical methods and employs laboratory safety polices at all times. Work assignments will encompass performing and documenting activities from routine to semi-routine in nature, evaluates data against defined criteria/ specifications, trends, and require the ability to recognize deviations from the accepted practice. The analyst will be responsible for the timely completion of assignments, maintains laboratory supply inventories, and maintains the laboratory in an inspection-ready state. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime and weekends as required, and expected to spend between 80-90% of his/her time in the laboratory.
The analyst is required to develop and maintain proficiency in a broad range of trained test methods, assists in the revision of written procedures as assigned, assists in the preparation of routine and non-routine study protocols and reports, and trains peers in areas of expertise.
The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers. The analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills to work with their supervisor/manager in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation.
B.S./B.A. in Science (major in biology-biochemistry-chemistry) with 0-3 years of relevant laboratory experience
Familiarity with cGMP, LabWare LIMS, CMMS, and/ or TrackWise.