Quality Assurance Specialist

Our BusinessAdare 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 CultureWhen 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.PositionQuality Assurance SpecialistLocationVandalia, OhioSummaryThe Quality Assurance Specialist is responsible for the audit of batch production documentation (manufacturing records, analytical records, deviation investigations), Development support, Contract Manufacturing oversight, disposition of product, approving quality documents (e.g. SOP, protocols, methods), and ensuring adherence to cGMP.ResponsibilitiesAudit Analytical testing and executed Batch Production Records.Review and approve Deviations and Lab Investigations.Coordinate and support Quality Assurance aspects of Product Development and Contract Manufacturing activities.Perform cleaning verification visuals and swabs.Release in-process materials for further processing and finished products for shipment.Interact with Customer’s Quality associates as necessary.Maintain and ensure correctness of documentation.Interface with all departments within the company.Ensure facility adherence to cGMP.Maintain the confidentiality of pertinent information.Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.Follow other job-related instructions and perform other tasks as required.Attends work on a regular and predictable basis.Completes assigned tasks in a safe manner and in a constant state of alertness.Perform other tasks as required.Experience, Education, And Skills RequiredBachelor’s Degree preferred, with at 3+ years’ of Quality experience in a pharmaceutical or similarly regulated industry.Experience using a Quality Management System; experience with V eeva preferred. Experience with using the Microsoft Office Suite of software (Word, Excel, PowerPoint) is preferred.Knowledge in cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment is preferred.Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation systems is highly preferred.Accuracy and neatness of compiling documents.Attention to detail.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 ONLYNO AGENCIES OR THIRD PARTIES