Quality Assurance Specialist-Manufacturing O pracy Ability to identify and report on QA events related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operationsResponsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.Provides review of production specific Deviations / Investigations, CAPAs, Change ControlsAssist in generating procedures related to Manufacturing QA functions / activitiesObserve and identify conformance to defined procedures and batch specific steps within the aseptic areasPeriodically review records to verify that quality standards for each drug product is metMaintain compliance with FDA 503B and cGMP guidelines / state and federal lawsPrepares weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunitiesResponsible to maintain all testing equipment in compliance, calibration and certification.Assists in developing policies and procedures related to QAPromptly communicates with Operations regarding complaints, product issues/variances.Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliationEnforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles. Support all regulatory and customer quality audits.Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantlyAssist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.Conduct and report the findings of internal investigations of compliance issues. Postaraj wyróżnić się na tle innych BS/BA degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated fieldMinimum 2 years directly related experience supporting compliance in a quality/compliance function /applicable compliance field.Ability to effectively communicateDecision making abilityOversight of operations with a focus on Sterility AssuranceAbility to multi-task and prioritizeExperience supporting compliance in a quality/compliance/ function /applicable compliance field preferredKnowledge of QMS and CAPA related tools or systems is preferred.Environmental, monitoring or audit experience is an assetExperience with inspections and inspection readiness activities preferred.Personal leadership with demonstrated competency interfacing with department leads preferred.Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.Excellent communication skills.Listening, interpreting and summarizing informationClear and concise verbal communicationProfessional and concise written communications –exceptional attention to detailStrong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.Strong project management skills: MS Word, Excel, PowerPoint,Flexible and able to adapt to company growth and evolving responsibilities. Mail-a-friend Udostępnij informację na temat tego wakatu: