QA/QC Specialist III
Integrated Resources, Inc ( IRI )Cambridge, Massachusetts, United States
Posted December 21, 2015
Full Time
About the Company
Integrated Resources Inc. (IRI) is a leading professional staffing firm founded in 1996, specializing in contract, consulting, and full-time positions across Information Technology, Life Sciences, and Allied Healthcare. With a focus on quality and commitment, IRI offers comprehensive services including CRO clinical research, engineering management, and regulatory drug development. Their expert team of counselors partners with candidates and clients to find tailored solutions, distinguishing them in the industry through personalized service and extensive expertise.
Job Description
The QA/QC Specialist III will work in the External Quality Assurance Department, overseeing contract manufacturing operations, supply chain operations, and supplier quality functions. The individual will support the execution of quality systems, including the external audit program, and provide QA guidance and review for Product Development projects.
Requirements
- Bachelor's degree in chemistry, biology, or a related discipline
- Minimum 5 years Quality Assurance experience supporting the manufacture of drugs, biologics, or devices
- Experience in applying phase appropriate cGMP's to Clinical Product Life Cycle
- Understanding of quality systems, cGMPS, and Regulatory Agency guidance as applicable to drugs or biologics
- Excellent interpersonal and professional skills with the ability to communicate well orally and in writing
- Strong Quality Assurance knowledge, previous experience in QC a plus
- Ability to prioritize and multitask in a dynamic environment
