Quality Assurance Specialist

Adare Pharma Solutions•Vandalia, OH

1d•Onsite

About The Position

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 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.

Requirements

Bachelor’s Degree preferred, with at least 2+ years of Quality experience in a pharmaceutical or other GMP regulated industry.
Experience using a Quality Management System; experience with Veeva 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.

Nice To Haves

Experience with Veeva
Experience with using the Microsoft Office Suite of software (Word, Excel, PowerPoint)
Knowledge in cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment
Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation systems

Responsibilities

Disposition Product
Review executed Production Records, Packaging Records and Analytical results for compliance to established internal procedures, methods, specifications and industry standards
Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP and resolves major issues that are not defined by SOP.
Conduct product release activities for intermediates, drug product and finished goods including review and approval of master batch records and executed batch records.
Ensure deviations are properly documented and investigated.
Approve Corrective and Preventive Actions.
Ensure compliance with Quality Agreements.
Support customer service-related business activity, as appropriate.
Maintain the confidentiality of pertinent information.
Review and approve master and executed manufacturing / packaging records.
Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition.
Actively participates on project teams as assigned by management.
Completes all assigned training by target due dates.
Participates in internal audits as assigned by management.
Interface with all departments within the company
Be an ambassador for Quality within the company
Maintain professional interactions with all departments and other sites
Ensure facility adherence to cGMP
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