Job description Client is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries. Reponsibilities Need mid-level (10+ yrs) Sr. Specialist to provide QA oversight for GXP computer systems validation projects (LIMS and Electronic Laboratory Notebook (ELN) System) by conducting the review (including detailed comments/observations) of validation documents and associated discrepancies. Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines. May attend cross-functional meetings to support the operation of computerized systems. May participate in the improvement and development of Quality Systems to ensure quality and adherence to cGMPs. Desired Skills and Experience: Must have biopharmaceutical experience with knowledge of FDA regulations along with application of cGMP and cGDP. . Understand industry standards related to validation. Ability to write detailed investigation reports and qualification/validation documents that consistently meet Company and regulatory agency requirements. Verbal and written communication skills. Must be able to read, write, and converse in English.
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