Operations Associate, Quality Assurance Job in Edison 08817, New Jersey Us
Job Summary: We currently have an opening for a Operations Associate, Quality Assurance, in our Edison, New Jersey location. This position will conduct quality assurance operational activities key to supporting GXP systems and processes within DSPD QA. Activities include: managing audit, inspection and CAPA information and documentation to ensure follow up and closeout activities are performed in a timely manner, providing operational support to key QA functions (e.g. SOP Committee), maintaining and updating information relating to training files to ensure that all training files remain current, and assessing annual stability reports for accuracy and compliance. Responsibilities: In this role, you will manage and track QA audit information e.g., compiling and processing written communications, tracking CAPA information, and identifying and reporting related timeline outliers to QA Managers. Management, entry, maintenance, QC and assessment of QA databases, e.g, Training, and Trackwise databases. Manages relationship of employees/contractors to their required training, updating the Training database accordingly and creating training logs as required.SOP/SOI operational management: The Quality Assurance Operations Associate is responsible for coordinating the review of SOP/SOI proposals and SOP reviews, tracking the expiration of procedures, identifying procedures due for imminent expiration and proactive notification of procedural owners. The Quality Assurance Operations Associate is also responsible for tracking action items from SOP Committee Meeting minutes to completionProvides operational support for Regulatory Inspections and Global QA meetings with compiling, tracking, and summarizing of informationManage the QA archival and retention requirements ensuring QA is in compliance. This includes QC and reconciliation of files for completeness and inspection readiness and communication with QA Managers to ensure timely update of files, and communication with QA Leadership on areas of non-compliance. Metrics compilation: this entails collection and maintenance of QA audit data, and subsequent analysis and reporting to QA management, to support QA's provision of audit information to Daiichi Sankyo functional management. Quality Agreement Coordination:a. Maintains quality agreement database (both hard copy and electronic)b. Intake all new quality agreements, assign identifier to each new agreement and disseminate as necessary for read and signc. Execute the review of quality agreements based on DSI SOP mandated triennial review Annual product review coordination:a. Compile APR information from all contractors and provide initial review and edit of APR.b. Route APR for departmental review and final approval Education/Experience Qualified candidates must have a High School degree or equivalent and 5 years of relevant experience or Associates degree and 3 years of relevant experience. Minimum two years experience in pharmaceutical operations including knowledge of GXP systems; Pharmaceutical Quality Assurance experience and knowledge of Quality systems operation preferred.Understanding of general QA principles and GXP compliance issues as they relate to the management of drug product quality and clinical trial quality oversight. Ability to read, understand and competently execute activities in accordance with approved SOPs, sampling plans, checklists, guidance documents and management direction. Ability to effectively communicate both verbally and in writing. Ability to interact effectively within a diverse cultural environment.Detail oriented. Knowledge of QC/QA processes, FDA GMP regulations and ICH Guidelines. Proficient in advanced functions and use of PC software packages (particularly MS Office Suite), including spreadsheets, word processing, graphics, etc., to produce high quality reports, presentations, or other documents
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