Packaging Quality Specialist

Our Business Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines. By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.” Our Culture When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space. In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day. Why Come to Adare? Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth. We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage. Position Packaging Quality Specialist Location Philadelphia, PA Summary The Packaging Quality Specialist is a critical member of the Operations team, responsible for all documentation and procedural activities associated with batch records, non-conformance investigation reports and actions that come out of the reports. This includes investigation, analysis, and writing of non-conformances and the associated reports. Responsibilities * Provide documentation services to the Packaging department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files. * Support all Quality Systems for the Packaging Department, including CAPA, Change Control, NCIR tracking/trending. * Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidance and guidelines. * Review, update and approve Standard Operating Procedures (SOPs) and other official documents. * Identify appropriate Corrective Action, Preventative Action (CAPA) as needed. Responsible for completion of CAPA and follow-up on effectiveness. * Support all Continuous Improvement efforts within the department. * Aid in support and help maintain a system for pre-campaign activities for all packaging processes. * Develop and maintain a system for monitoring and reporting department metrics on a continual basis. * Develop, plan, track and analyze assigned projects. Works with project sponsor (s) to define project success criteria, timelines, milestones and deliverables. Identifies project dependencies and critical paths. * Effectively communicate and manage project expectations and success criteria to project sponsors, team members, vendors and other stakeholders in a clear and concise manner throughout the project lifecycle. * Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidance and guidelines. * Support Packaging Manager in reducing compliance risk by aiding in performing internal audits and developing action items to correct risks * Perform all these functions, and others, as required by the Packaging Manager in a professional and timely manner. * Follow and observe all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility. * Works effectively under deadlines. * Respects policies, procedures and regulations in force in the company. * Completes assigned tasks in a safe manner and in a constant state of alertness. * Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code Experience, Education, and Skills Required * Bachelor’s degree in writing, math, science or engineering field * 2+ years’ experience technical writing and/or procedure development, preferably in FDA regulated environment. * Proficient with Microsoft Office (Excel, Word, PowerPoint). * Capable of organizing data from multiple sources, extracting key information and writing reports and summaries * Demonstrated ability to write logically and consistently * Assertive Influencing & Collaboration/Teaming Skills * Strong decision making and problem-solving skills * Excellent interpersonal written and oral communication skills * Able to prioritize duties and manage multiple projects from start to finish with minimal supervision. * Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. * Exceptional attention to detail and excellent organizational skills Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES