QA Associate I/II (Temporary) - United States
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- 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.
- QC cGMP experience beneficial.
- Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.
- Demonstrated working knowledge related to specific functional activities.
- Ability to perform most tasks with supervision.
- Computer literacy is required.
- Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.
- Must have excellent record keeping, written and verbal skills.
- Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays. Efficient in scheduling and facilitating the execution of routine and non-routine testing.