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QA Associate I/II (Temporary) - United States
Posted on : 02 June 2017
- 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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.