QC Associate II

Integrated Resources Inc.; Raleigh (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

A leading staffing firm is seeking a Quality Control Raw Materials Associate II to ensure compliance with industry regulations and support manufacturing processes. The ideal candidate has a strong background in analytical techniques and experience in a cGMP environment, primarily within the pharmaceutical or biotechnology sectors. This role involves performing detailed testing and analysis of raw materials, following stringent quality standards and protocols.

Qualifications

• 3-5 years’ experience in a cGMP environment in the pharmaceutical or biotechnology industry.
• Proficiency in analytical techniques and compliance knowledge.
• Experience in performing compendial analysis.

Responsibilities

• Perform qualification of Raw Materials, protocols and reports.
• Conduct testing such as compendial analysis on raw materials.
• Support manufacturing based on cGMP's and internal procedures.

Skills

Analytical techniques

Problem solving

Communication

Troubleshooting

Organizational skills

Education

B.S. degree in the Sciences, preferably Chemistry

A.S. Degree in Chemistry

Tools

Chromatography

HPLC

GC

Spectroscopy

Karl Fisher

Job description

A Few Words About UsIntegrated 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.

Job Description

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.