The Contract Analyst under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples. Contract Analysts work independently on assays that he/she has mastered. They must be able to work on projects with little supervision, write and execute method validation and special studies, and have some oversight of a product line.
Perform, under moderate supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. Work independently on assays that he/she has mastered.
Evaluate data against defined criteria/specifications.
Maintain laboratory supply inventories.
Maintain the laboratory in an inspection-ready state.
Provide support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory.
Develop and maintain proficiency in a broad range of test methods.
Assist in the revision of written procedures as assigned.
Assist in the preparation of routine and non-routine study protocols and reports.
Train other analysts in areas of expertise.
Develop familiarity concerning cGMP, 21CFR, USP, EP, and ICH regulatory
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,
Good written, verbal, and communication skills.
Strong documentation skills.
Bachelor’s Degree in science (major in biology-biochemistry-chemistry) with 5 years of experience