Quality Assurance Specialist

Company Overview

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.”

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 Join 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.

Benefits

• Medical, dental, and vision coverage
• 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)
• Disability coverage

Position Summary

The Quality Assurance Specialist is a key player on the Quality Assurance team, responsible for auditing batch production documentation (manufacturing records, analytical records, deviation investigations), providing development support, overseeing contract manufacturing, disposition of product, approving quality documents (e.g., SOPs, protocols, methods), and ensuring overall adherence to cGMP.

Responsibilities

• Disposition Product: Review executed production, packaging, and analytical records for compliance with internal procedures, methods, specifications, and industry standards; resolve minor documentation issues and major issues 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.
• Investigations: Ensure deviations are properly documented and investigated; approve corrective and preventive actions.
• Interact with Customers: Ensure compliance with Quality Agreements; support customer‑service‑related business activity as appropriate; maintain confidentiality of pertinent information.
• Third Parties: Review and approve master and executed manufacturing/packaging records; work with CMOs to raise, investigate, and resolve deviations and investigations prior to lot disposition.
• Projects: Actively participate on project teams as assigned by management.
• Training: Complete all assigned training by target due dates.
• Audits/Inspections: Participate in internal audits as assigned by management.
• Interface with all departments within the company and act as an ambassador for Quality.
• 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.

Experience, Education, and Skills

• 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.
• Proficiency with the Microsoft Office Suite (Word, Excel, PowerPoint) preferred.
• Knowledge of cGMP as related to records and documentation in bulk pharmaceutical and solid oral dosage manufacturing environments preferred.
• Knowledge and/or working experience with large processing systems, fluid air systems, and/or coacervation systems highly preferred.
• Accuracy and neatness in compiling documents; strong attention to detail.

Physical Demands

The physical demands described are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, use hands and fingers to manipulate objects, tools, or controls, and reach with hands and arms. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl, and to talk or hear. Specific vision abilities required include close vision, color perception, peripheral vision, depth perception, and the ability to adjust focus. Additional demands include standing, walking, pushing, pulling, twisting, reaching overhead, and bending to the floor; wearing a respirator when working with chemicals of specified potency; occasionally moving items or equipment weighing up to 25 pounds (heavier materials may be handled with mechanical assistance); occasionally climbing ladders or steps to reach equipment; and reading precision measuring equipment, machine dials, gauges, and thermometers, including observing fine details using a microscope.