Analyst, QC Analytical

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Duties:

The Quality Control Analyst is responsible for performing microbiological, biochemical and chemical tests of in-process product, equipment, and manufacturing facilities.

The incumbent will be responsible for performing microbiological and analytical testing under cGMP guidelines.

Functional activities may include: performing a wide variety of tests for microbiological, biochemical, and chemical assays, supporting process validation studies, conducting investigations, analytical method or equipment validation, assay method/procedure development, and reagent preparation.

The position requires knowledge of but is not limited to:

HPLC, Enzyme activity, protein by UV spectrophotometry or Bradford/BCA, kinetic chromogenic endotoxin, bio burden determination, Total Organic Carbon, microbial identification, aseptic techniques, microbial challenge studies, microbiological method validation, and other similar analysis methods.

Work assignments will encompass activities from routine to complex in nature with the ability to recognize deviations from the accepted or routine practice.

The incumbent will be responsible for completing assignments in a timely manner, for assay troubleshooting, data trending, and for follow-up on any testing issues.

The incumbent should be able to work independently and prioritize multiple tasks.

Good record keeping, organizational, written and verbal communication skills are essential.

The incumbent must be willing to work second shift, overtime, weekends and holidays as required.

Perform microbiological/ biochemical/ chemical analyses of in-process product, facility and utility testing under cGMP to meet specified timelines.

Assist with the preparation of investigations, technical reports and trend reports.

Support method validation, transfer, routine, and non-routine study protocols.

Control laboratory inventories.

Maintain the laboratory in an inspection ready state.

Provide backup support of analytical chemistry/biochemistry assays for Analytical and Raw Materials Groups.

Provide on call coverage for Action level conditions to support production testing and quality control laboratory equipment.

Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.