Location: Cambridge, MA (Occasional Commute to Norton, MA)
Duration: 7 Month Contract to Start
Benefits: Real staffing offers medical, dental, 401K, short/long term disability
A growing, global Pharma company is seeking an experienced QA Specialist to join their Supply Chain QA group. This individual will be responsible for the review and approval of Validation life-cycle documentation for facility, equipment, utilities, laboratory equipment qualification, as well as process performance qualifications. Additionally, they will support the Facilities Group and Internal Manufacturing operations staff with the review and approval of Calibration Plans, risk assessments, change controls, deviations and CAPAs.
QA review and approval of deviations, change controls, CAPAs and Engineering Change Controls
QA review and approval of executed batch records
Disposition of Raw Materials
QA review and approval of work orders
QA review and approval of SOPs
Bachelor's Degree in a life science, engineering or related field
7+ Years of experience in a Quality, Validation, GMP Manufacturing, and/or Supply Chain Environment
Previous experience in a Pharmaceutical/Biotech Industry Environment
Strong working knowledge of Quality Systems, GMPs and ICH Guidelines
Demonstrated teamwork, initiative, problem-solving, and project management skills
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
To find out more about Real please visit www.realstaffing.com