About this role
Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.Collaborating with cross functional client Quality and other PSS site team.Collecting data from various process areas, defect reports and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.Generate regular investigation, training reports to provide visibility into quality performance. Manage quality improvement activities, meetings and other activities supporting the work of the departments.Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision making.Evaluate and managing resources and task- understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.Assist with other aspects of quality improvement including administrative and operational support as needed.Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements. To ensure adherence with quality standards and best practices.Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continues improvement throughout the organization.Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.QA Essential Duties and Responsibilities:
Applies GMP/GLP in all areas of responsibility, as appropriateDemonstrates and promotes the company's visionRegular attendance and punctualityEnsure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality systemCoordinate workflow and perform daily monitoring to meet TATPerform and/or assign other duties as requested to ensure the smooth operations of department Bachelor’s + 2 years of relevant industry experience, or Master's degree in a scientific field such as Pharmacy, Biology or Chemistry +1 year of relevant experience. Relevant experience may include:Quality investigations, deviations, audits, CAPAs, quality management systems, controlled document storage, etc. Pharmaceutical industry experienceStrong knowledge of global regulatory and cGMP requirements, industry best-practicesExperience with manufacturing operations.Strong technical writing ability Position is full-time, Monday-Friday, 8:00 AM - 4:30 PMPay range: $26.25 - $30.00Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEligibility for potential yearly Bonus & Merit-Based Pay IncreasesLinkedIn: #LI-EB1Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.