Performs, under direct to minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
Evaluates data against defined criteria/specifications.
Works independently on assays that they have mastered.
Develops and maintains proficiency in a broad range of trained test methods.
Trains other analysts in areas of expertise.
Maintains the laboratory in an inspection-ready state.
Maintains laboratory supply inventories.
Ensures that support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory are completed to meet business needs.
Develop familiarity concerning cGMP, 21CFR, USP, EP, and ICH regulatory requirements.
Interacts with other departments at client as appropriate.
Holds self and others responsible to abide by department and company policies and practices.
Assist in revision of written procedures as assigned.
Other duties as assigned.
Skills:
Required Skills:
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 and Excel.
Good written, verbal, and communication skills.
Good documentation skills.
Demonstrates the ability to work independently.
Desired Skills:
At least one year in a cGMP/GLP laboratory; quality control experience is preferred.
Education:
B.S./B.A. in Science (Major in Biology, Biochemistry, or Chemistry) with at least 2-3 years of relevant laboratory experience or A.S. with at least 4 years of relevant laboratory experience