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Pharmalearner

Compliance Specialist III || Framingham, MA || Type-2 Year Contract ||$35-40/hr

Pharmalearner, Framingham, Massachusetts, us, 01704


Responsibilities:Perform audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation.Establish auditing requirements, quality standards, and test methods in accordance with regulations and relevant quality requirements.Conduct internal audits of manufacturing processes to ensure compliance.Conduct review of testing results.Review documents and complete inspection of returned goods.May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control.Interpret complex, explicit documentation to ensure quality standards and compliance.May provide training to new employees.Work under only very general supervision.Work is reviewed for soundness of judgment and overall adequacy and accuracy.Contribute to the completion of organizational projects and goals.Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.Frequent internal company and external contacts.Represent organization on specific projects.Qualifications:BS/BA degree in a Scientific/Manufacturing/Quality Assurance discipline.Years of Experience: 6 – 9 YearsSkills:

SOP, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)

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