Senior Specialist, Quality Assurance

RESILIENCE US INC • Hamilton, OH • 5h ago

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.For more information, please visit www.resilience.comPosition SummaryThis position is responsible for all QA activities that directly support execution of the process both within the Operations Teams and in assigned areas outside of Operations. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.Position Responsibilities Maintain a high level of understanding of relevant production processes and quality systemsPerform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:Change RequestsBatch Records and associated documentationProduct and Component Release transactions in SAPQuality Investigations (Deviations, Product Complaints)Validation Plans, Protocols and ReportsStandard Operating ProceduresAccountable for disposition (release or rejection) of incoming materials and finished packaged productCollaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systemsExecute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectivesInterface with applicable site support groups on projects (capital and non-capital) that impact the operations/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projectsCollaborate with and influence other Operations/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practicesStay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leadersCollaborate in data analysis and report creation on quality metrics and key performance indicatorsStrong collaboration between other areas to ensure consistent application of quality systems/processes across the siteAbility to work independently with minimal guidance from managementInfluence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for considerationDemonstrate leadership capabilitiesTrain and mentor junior members of the QA organization and provide QA coaching to other non-QA employees within the area supportedStrong performance history of consistently meeting or exceeding expectationsHold other accountable for high standards and clarify what needs to be accomplished, why, and the consequences for the individual and/or the organizationDemonstrate a strong understanding of the technology area to which the individual is alignedAct as an execution lead/process owner for one or more processesMinimum RequirementsPrior experience in either the pharmaceutical industry, an operations environment, or Quality AssuranceStrong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environmentExcellent oral and written communication skillsStrong ability and motivation to learnStrong problem-solving skillsAbility to coach and mentor peersPreferred BackgroundBachelor's degree or master's degree in quality assurance /regulatory affairsPrevious experience in a Lean, process-centric organization with emphasis on continuous improvementMulti-site / multi-functional experienceSponsorsh

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