The Quality Control department is responsible for support of the Manufacturing department and external customers. The primary functions of the laboratory are raw material, in-process, finished product and stability testing. Laboratory testing encompasses assays performed on raw materials and drug product at various stages to determine product safety and quality.
This position is responsible for activities relating to the daily function of the Quality Control laboratory and strategic planning for the laboratory and laboratory staff. The individual is the subject matter expert on analytical testing. The individual is heavily involved in partner and regulatory audits, site metrics meetings, site-wide improvement projects, budgeting and data review and interpretation, including protocols, investigations, and laboratory documentation. This position is responsible for the entire laboratory team, and is required to perform staff management duties such as reviews, disciplinary action, and ensure training is performed. The individual operates with very limited supervision and must be able to work both independently and on teams.
Education / Experience:
Bachelor’s degree in chemistry. Seven or more years of professional experience. Broad knowledge of scientific principles and methods, wet chemistry, chromatographic analysis, analytical methods (i.e., HPLC, GC, UV), and an understanding of separation theories. Good written and verbal communication skills; highly organized. PC literate with basic knowledge of MicroSoft office application software.
Judgment / Decision Making:
Under general direction toward broad assignments with periodic reviews. Duties performed within a framework of departmental or functional protocol requiring a high degree of original thinking.
Laboratory environment with exposure to chemicals, caustics, fumes, electrical current, and odors.
Visual acuity and manual dexterity required to operate computer and proofread documents.