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Posted 128 months ago

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QC Associate II

RaleighOn-siteContract

AI Summary

Performs quality control testing and qualification of raw materials for pharmaceutical or biotechnology manufacturing, following cGMP and compendial standards.

About this role

QC Associate II

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

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.


Qualifications

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.


Skills

Compendial AnalysisConductivityGCHPLCKarl FischerOsmolalityPH MeasurementPolarimetrySpectroscopyTitrimetryTOC

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