Quality Assurance Specialist

The Quality Assuance Specialist plays a key role in ensuring that all materials used in manufacturing meet stringent quality and regulatory standards. Working within a global, interconnected Quality organization, this role supports the assurance of product quality through microbiological, chemical, and analytical testing. The position collaborates closely with Production, Quality Assurance, Validation, Facilities, and external partners to maintain a compliant, reliable supply of high-quality products to patients worldwide.

Responsibilities

• Conduct release testing in support of finished products
• Perform microbiological testing and evaluate environmental microbiological samples
• Execute environmental monitoring (active air, surface, and water sampling)
• Conduct in-process and release testing
• Evaluate data, troubleshoot issues, and participate in process improvements
• Write reports and contribute to cross-functional projects and committees
• Maintain laboratory materials, reagents, and equipment
• Complete assignments aligned with departmental objectives
• Identify and resolve technical or operational problems with guidance as needed
• Communicate effectively, ask questions, and verify understanding
• Make routine shop-floor decisions guided by existing policies and procedures, escalating complex issues when necessary

Education

• Associate’s degree in Biology, Microbiology, Biochemistry, or related field plus 1–2 years of relevant laboratory/pharmaceutical experience
• Bachelor’s degree in Biology, Microbiology, Biochemistry, or related field

Experience

• Understanding and application of Good Laboratory Practices (GLP) and cGMP
• Proficiency in aseptic technique
• Experience performing environmental and water systems monitoring
• Ability to work effectively in a team environment
• Preferred: Strong verbal and written communication skills
• Preferred: Experience with LIMS, SAP, or laboratory/production software systems

Additional Information

• Shift: Monday–Friday, 10:00 AM – 6:00 PM
• Ideal candidates are intellectually curious, collaborative, and motivated by work that helps save and improve lives