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QA Specialist, Continuous Improvement

Company: Renaissance LLC
Location: Lakewood
Posted on: January 6, 2022

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.OverviewThe QA Specialist, Continuous Improvement will maintain and review all Corrective Actions/Preventative Actions (CAPAs), and Effectiveness checks in the Trackwise system. The Specialist will work with other departments to ensure records are in their proper state as well as review and write cGMP procedures under supervision. The QA Specialist will maintain and report quality metrics and perform the trending of data.Responsibilities--- Interact with CAPA and Effectiveness check owners to assist in the completion of the records.--- Review all CAPAs and Effectiveness checks submitted to Quality.--- Run department CAPA Meetings when required.--- Maintain and report all required Quality metrics. --- Perform trending of metric data.--- Lead process improvements and projects within the company.--- Assist with document retrieval during audits.--- Provide training in the Trackwise system to ensure effective use of the system.--- Write deviations/notifications/change controls as required--- Assist the training department as required.--- Complete action items assigned through TrackWise--- Update SOPs as required--- Perform other tasks as requested by management.QualificationsBachelor's degree required, science related degree preferred or equivalent work experience in a Quality departmentPrefer at least 2 years of relevant experience in the pharmaceutical industry and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.Proficient with MS OfficeExperience with Trackwise preferredPI159250026

Keywords: Renaissance LLC, Lakewood , QA Specialist, Continuous Improvement, Other , Lakewood, New Jersey

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