QC Associate II

Qualification & Job Responsibilities:

The Quality Control Raw Materials Associate II will possess technical knowledge regarding Quality Control Raw Material methodologies. The position requires but is not limited to the following: demonstrated technical and analytical abilities, solid oral and written communication skills; ability to communicate with management and peers effectively and in a timely manner, effective organizational skills, developing or demonstrated problem solving skills, developing or demonstrated instrument/method troubleshooting skills, general knowledge of USP/PhEur regulations and compliance.

Responsibilities

• The ideal candidate will perform qualification of Raw Materials, protocols and reports, perform testing such as compendial analysis on raw materials per the USP, PhEur, JP or ACS monographs and general chapters in support of manufacturing based on cGMP's and internal procedures.

Qualifications

• The candidate must demonstrate knowledge and proficiency in analytical techniques. Compendial experience per USP/PhEur is a must.

• Additional techniques include titrimetry, pH, osmolalrity, Karl Fisher, polarimetry, spectroscopy, Total Organic Carbon and Conductivity. Additional experience in chromatography, including HPLC and GC, is a plus.

Education

• B.S. degree in the Sciences, preferably Chemistry, with 3-5 years’ experience in a cGMP environment, preferably in the pharmaceutical or biotechnology industry.

• A.S. Degree in Chemistry with 6-9 years’ experience in a cGMP environment, preferably in the pharmaceutical or biotechnology industry.