What are the responsibilities and job description for the QC Analyst I - Vacaville, CA position at Unicon Pharma Inc.?
Description:Summary:With limited supervision, QC Associate I, is responsible for the performance of direct materials testing in accordance with cGMP regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.Job Responsibilities:Perform a broad variety of basic and moderately complex tests with documentation according to GMPReview data and assess against established acceptance criteriaPerform technical review of peer-generated dataEvaluate data to identify trends and/or establish limits Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as neededIdentify and troubleshoot technical problemsIdentify gaps in systems and proceduresReceive and provide trainingParticipate in assay transfer and assay validationPerform equipment qualification / maintenancePrepare and maintain standards, controls, stocks, cultures, etc. per established proceduresSupport the maintenance and compliance of operational areasAssure and apply GMP throughout operationsCoordinate with customers to support multi-site operational activitiesSupport internal and external audits and regulatory inspectionsWorks to meet schedules, timelines, deadlinesParticipate in and/or lead group and project teamwork; project and process improvementsWrite protocols and reports under limited supervisionMeets scheduled performance of 95% on timePerform other duties as requested by managers to support Quality activitiesJob RequirementsB.S./B.A. degree and 1-3 years experience or Master’s Degree plus one year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.Strong verbal and written communication skills, ability to organize and present information both formally and informally.Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.Routinely exercises sound judgment, reasoning and problem solving.Capable of working under limited supervision and determining own short term priorities.Enable Skills-Based Hiring No
Salary : $27 - $37