QA Associate, Validation

Veritude

Quality Assurance

November 25, 2009

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.

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About MassBio

MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.

Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.

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