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Robert Ciociola posted a job:

"Now Hiring: Quality Systems Manager CD 319 in Fort Washington, PA Quality Systems Manager CD-Fort Washington,PA Contract Position-27 months send resumes to: bciociola@covexllc.com Job Description/Major Responsibilities: The Quality Account Manager CD will maintain specific Quality Systems to meet the current FDA Regulatory requirements for the External Manufacturing site to ensure strong compliance is maintained across all elements of new product transfer, manufacturing, testing, packaging and distribution. These Quality Systems include (but are not limited to): CAPA and Non-Conformance robustness, Document and Records Management, Complaints Management, Change Control, Non-Conformances Management, Validation of products and processes, Product Release, SAP Master Data, and GMP/Compliance Training. This individual will implement decisions on process and system strategy recommendations, defining compliance-driven standards, determining boundaries for harmonization and alignment versus differentiation. The Quality Account Manager CD will support other duties as provided by the CD organization Education: Bachelors Degree in Chemistry, Microbiology, or science related discipline required. Advanced degree preferred. Experience/Technical Competencies: Oversee EM Quality Systems, as assigned by Associate Director, to assure compliance with regulatory requirements. Systems include (but are not limited to) CAPA and Non-Conformance robustness, Document and Records Management, Complaints Management, Change Control, Non-Conformances Management, Validation of products and processes, Product Release, SAP Master Data, and GMP/Compliance Training. Required Job Knowledge Skills/Abilities: Experience with non-conformance and CAPA systems, documentation and technical writing skills, in a regulated compliance environment, is preferred. Must exhibit thorough understanding of FDA requirements. 5 years in a quality and/or compliance environment in the pharmaceuticals industry. Experience in the Pharmaceutical, Medical Device and Diagnostic and/or OTC industry is required. Experience in working within a strictly regulated GMP environment is required. Experience working in an FDA regulated environment is required Travel: <10% travel is anticipated in this role http://bull.hn/l/R3F0/4"

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