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Analyst II/Sr. Analyst, Quality Control

The Quality Control Sr. Analyst, under minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples. The Senior Analyst 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.

RESPONSIBILITIES

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 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 method validations, protocol, and report writing.
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 at least 2-3 years of relevant laboratory experience or Associates Degree in science with at least 6 years of relevant laboratory experience for an Analyst II, and Bachelor’s Degree in science (major in biology-biochemistry-chemistry) with at least 5-6 years for a Senior Analyst.
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