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/specifications.
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.
Required: At least two years performing molecular biology techniques. Proficient in good pipetting 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.