Analyst, QC II (Temporary) - United States
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- 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 Contract Analyst II, 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 at first under direct supervision and then 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.
- This position requires willingness to undergo training on basic as well as 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, and require the ability to recognize deviations from the accepted practice.
- The analyst will be responsible for the timely completion of assignments.
- Good record keeping, organizational, written, and verbal communication skills are essential.
- The analyst must be willing to work overtime and weekends as required.
- Performs, under direct or minimal supervision qPCR, ELISA and other molecular biology analyses of test samples under cGMP to meet specified timelines.
- Works independently on assays that he/she has mastered and under direct or minimal supervision for those assays that are more complex.
- Evaluates data against defined criteria/specification
- Maintains laboratory supply inventories.
- Maintains mammalian and insect cell lines.
- Provides support for routine laboratory functions/chores for the QC laboratory.
- Develops and maintains proficiency in a broad range of trained test methods, mainly qPCR and ELISA.
- Potentially including: aseptic cell culture technique and gel electrophoresis.
- Assists in the revision of written procedures as assigned.
- Trains other analysts in mastered techniques.
- Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
- Interacts with other departments, including but not limited to Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
- At least two years performing molecular biology techniques. Proficient in good pi petting techniques, handling micro volumes, and working with high throughput assay formats (96-well and above).
- At least two years in a cGMP/GLP laboratory quality control experience is preferred.
- Ability to follow written instructions and to perform tasks with direct or minimal supervision.
- Familiarity with use of a computer; e.g., Proficient in Windows, Microsoft Word, Excel, LIMS.
- Viral/gene therapy work experience is a plus.
- Good written, verbal, and communication skills.
- Good documentation skills.
- Demonstrates the ability to work independently.
- B.S./B.A. in a science major (biology/biochemistry/chemistry) with at least 2-3 years of qPCR, ELISA, and any other relevant laboratory experience.