Performs, under direct or minimal supervision, biochemical/physical/chemical 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 the laboratory in an inspection-ready state.
Provides support for routine laboratory functions/chores for the QC laboratory.
Participates in product/project coordination.
Assists in the revision of written procedures as assigned.
Assists in the preparation of routine and non-routine study protocols and reports and qualification documents.
Trains other analysts in areas of expertise on basic assays as well as more complex assays that are mastered.
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.
Manages data trends for critical reagents and reference material.
At least one year 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.
Experience with bioassay and/or HPLC techniques.
Good written, verbal, and communication skills.
Good documentation skills.
Demonstrates the ability to work independently
Detail oriented and organized
Ability to multitask
B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at least 2-3 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.
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.