Quality Assurance Specialist
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Responsibilities:
• Provide QA support on the floor for production
• Ensure process control measures are in place and followed in product manufacturing
• Receipt and disposition of incoming apheresis material.
• Oversee and authorize the shipment of final product
• Ensure all product-related Deviations are initiated, investigated and resolved.
• Ensure that associated CAPAs are initiated and resolved, as needed.
• Perform lot closure activities.
• Ensure approval and timely delivery of final product.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Basic Qualifications:
• BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR
• Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
• High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
Preferred Qualifications:
• BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Strong teamwork and collaborative skills
• Experience with manufacturing investigations, deviations, and CAPA.
• General knowledge of aseptic manufacturing processes.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description