Quality Assurance Specialist

About the Company

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

At Adare, employees across multiple countries and diverse backgrounds work together toward a common purpose. Supported by experienced and highly regarded leadership, we attract top talent from both within and beyond the CDMO space. We foster a collaborative, client-centric culture where employees support one another, share knowledge, and are encouraged to bring their best selves to work each day.

Why Join Adare?

Adare is Private Equity owned and poised for growth, offering internal development opportunities to progress within the organization. Employees can enhance their professional skills and industry knowledge through Adare’s investment in their growth. We provide opportunities across a variety of fields, 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

About the Role

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), supporting development, overseeing contract manufacturing, dispositioning product, approving quality documents (e.g., SOPs, protocols, methods), and ensuring overall adherence to cGMP.

Responsibilities

• Disposition Product:
  • Review executed Production Records, Packaging Records, and Analytical results for compliance with internal procedures, methods, specifications, and industry standards
  • Resolve minor issues found during documentation review (e.g., documentation errors, missing information) as directed by SOP
  • Resolve 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 the 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:
  • 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

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 Microsoft Office Suite (Word, Excel, PowerPoint) preferred
• Knowledge of cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment preferred
• Knowledge and/or working experience with large processing systems, fluid air systems, and/or coacervation systems is highly preferred
• Strong attention to detail and accuracy in compiling documents

Physical Demands

• Frequently required to sit, use hands and fingers, manipulate objects/tools/controls, and reach with hands and arms
• Occasionally required to stand, walk, stoop, kneel, crouch, crawl, talk, or hear
• Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
• Must be able to stand, walk, push, pull, twist, reach overhead, and bend to the floor
• Ability to wear a respirator when working with chemicals of a specified potency level
• Occasionally move items or equipment weighing up to 25 pounds (potential to handle heavier materials with mechanical assistance)
• Occasionally required to climb ladders and/or steps to reach equipment
• Must be able to read precision measuring equipment, machine dials, gauges, and thermometers; observe fine details utilizing a microscope