QA Associate, Validation
at Company:
Veritude
in Job Category:
Quality Assurance
posted on November 25, 2009
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Company
Veritude
Contact Name:
David Anderson
Email:
David.Anderson@Veritude.com
Website:
Visit Our Website
Job Reference Code:
26743
Description
We are looking for an Associate I, QA Validation on behalf of our client, Biogen Idec. This position is based in Cambridge, MA.
Responsibilities
• Responsible for performing GMP and technical review and approval of validation documents including qualification and requalification studies, and IQ, OQ, PQ studies related to QC Instruments, Manufacturing Equipment and their associated controlling software/automation.
• Performing GMP and technical review and approval of Change Control for the aforementioned instruments equipment and automation.
• Responsible for the review and approval of protocol deviations and will be responsible for ensuring resolution to all other protocol discrepancies.
• Review and approval SOPs related to the use and cleaning of equipment as well as master production records for appropriateness to the current validated ranges of the equipment and process.
Qualifications
• Familiarity with applicable US and worldwide regulatory requirements for the biotechnology industry.
• Special consideration is given to candidates with experience in sterilization (autoclave and SIP) validation and cleaning (CIP) validation.
Education
Bachelor's Degree and 2+ years Quality Assurance or Quality Engineering or equivalent experience preferred.
