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For your reference, we have included the original job posting below.
Quality Assurance Specialist
Job Number:
26843152
Company Name:
Blue Stream Laboratories
Job Location:
MA US
Job Category:
Information Technology
Quality Assurance Specialist
Blue Stream Laboratories, a fast-growing biochemical/analytical CRO, seeks a creative, highly-motivated individual who is ready for an exciting, entrepreneurial workplace, and who wants to contribute to a dynamic, success-driven team. Responsibilities: The Quality Assurance Specialist is responsible for independently performing multiple activities in support of Quality initiatives. Initiate and assist in investigations, resolving deviations, OOS/OOT and review corrective action plans for adequacy per GMP compliance requirements Provide support for document lifecycle maintenance including, but not limited to: Preparation/ inclusive of formatting of all GMP documentation, to include client interaction and correspondence Responsible for maintenance of all QA log books Assist in QA improvement projects, as required. Assist with hosting internal audits, as well as conducting internal and external audits Support review and disposition of controlled documents and associated raw data and subsequent archiving Support data trending, and providing metrics with minimal supervision. Assist with maintenance and organization of internal record-keeping to ensure compliance Consistently enforce employee compliance. Assist in providing QA support to laboratory staff Qualifications: Bachelor's degree or equivalent in a life science with 5-7 years experience. Experience with GMP document review, including certificate of analysis, specifications, BLA (NDA)/IND documents, methods, protocols, qualification, validation and analysis reports. Basic understanding of Quality Management Systems as well as pre-inspection readiness for regulatory audits which conforms to FDA, ICH, and other health agencies. Adapts diligently to new work requests with general instruction and guidance. Attention to detail in troubleshooting, as well as the ability to interpret and execute test plans, data and documentation review, and final disposition with minimal supervision. Excellent interpersonal skills and the ability to communicate well orally and in writing. To apply for this position, please email your resume to: . Please specify Job Code MBCQAS0824.
