Position Summary:The Quality Assurance Specialist II will provide intermediate-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components. In addition, this position is responsible for providing backup for the document and record control system. Extended work hours may be necessary in order to meet business demands.Essential duties include but are not limited to:Quality Function:Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):Non-ConformancesCustomer ComplaintsPlanned DeviationsChange ManagementCorrective and Preventive Action (CAPA)Supplier Quality ManagementAudit ProgramsEmployee TrainingDocument & Record ControlParticipating on the Material Review BoardAssist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activitiesMaintain monthly metrics and reporting tools for all aspects of quality systems, to include presentation of metric performance to management representativesRespond to supplier look-back notifications. Investigate and determine disposition of materialMonitor equipment calibration program to ensure timely and accurate completion of maintenanceIndependently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategiesManage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviewsOperations Support:Actively participate in daily operations as an on-the-floor QA representative and conduct process observations to written SOPs/accuracy of batch record/test method execution, and mentor personnel in industry best practicesServe as quality lead for validation activities, including review and approve validation protocols, reports, and final package documentationAssist in the QA review and acceptance of customer specifications to conform to contractual requirementsGenerate and maintain label formats for manufactured and resale productsGenerate and maintain Certificates of Analysis for finished products and products for resaleInspect and approve all product labels generated by OperationsProvide support to other departments regarding requests, release status, regulatory requirements and other tasks as requestedDevelop and distribute controlled quality system documentationWork with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and servicesDevelop and maintain databases/spreadsheets for document controlMaintain filing and storage systems for document control, training and batch records for raw and finished productPerform area walkthroughs and audits for compliance to written expectationsCollaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountabilityInspection and release:Inspect and release incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating proceduresPerform batch record review and release for finished product, raw materials, intermediate solutions, and servicesConduct product inspections, review repack recordsMiscellaneous:Participate actively on the safety committee, as neededAssist in training new and existing personnelParticipate in regulatory, notified body, and customer audits as neededProvide back-up coverage for other Quality SpecialistsCarry out other duties/projects as assignedQualifications:Minimum Required:Bachelors Degree or equivalent combination of education and experience2 years of related experience in a life science, regulated environmentOther Required:Experience working in a Quality Department, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvementsAbility to meet deadlines and perform administrative functionsMicrosoft Office suite proficiency including Office Word, Excel, PowerPointAbility to organize tasks, work independently and adapt to changing prioritiesAbility to function in a minimally supervised environment with exceptional attention to detail requiredDemonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skillsMust be able to read, write, speak, fluently and comprehend the English language#J-18808-Ljbffr

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