QA/QC Specialist III
Integrated Resources, Inc ( IRI )Cambridge, Massachusetts, United States
Posted December 21, 2015
Full Time
About the Company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Job Description
The QA/QC Specialist III will support the External Quality Assurance Department in overseeing contract manufacturing operations, supply chain operations, and supplier quality functions. The individual will be responsible for successful completion of quality systems, including the external audit program.
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
- Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
- Experience working with contract manufacturers
- Experience with Quality Control
- Experience with packaging and labeling operations
- Experience with TrackWise
- Experience with Medical Device, Small Molecules, and other pharmaceutical technologies
